Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 11:40 PM
Study NCT ID:
NCT01174550
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2010-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pamela.douglas@duke.edu', 'phone': '919-668-8700', 'title': 'Dr. Pamela Douglas', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Events occuring within 24 hours following the study intervention (initial test) were collected and reported by study personnel.', 'description': 'Severe Events/complications related to cardiovascular testing or cardiovascular procedures that are trial endpoints were collected throughout the duration of the trial and were considered related to testing or procedure only if occuring within 72 hours of test or procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing', 'otherNumAtRisk': 5007, 'otherNumAffected': 16, 'seriousNumAtRisk': 5007, 'seriousNumAffected': 161}, {'id': 'EG001', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing', 'otherNumAtRisk': 4996, 'otherNumAffected': 37, 'seriousNumAtRisk': 4996, 'seriousNumAffected': 168}], 'otherEvents': [{'term': 'Exercise Induced Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress Induced Symptoms Related to Functional Testing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemodynamic Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospital Admission Not In The Primary Endpoint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Any Event Potentially Related to Vasodilators', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Contrast Reaction (rash or hives)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extravasion of Contrast Into Surrounding Tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death- Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unstable Angina Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 61}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death - Non cardiovascular known cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death - unknown cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5007, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 4996, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Primary Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '90 days', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': '42 months', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.', 'unitOfMeasure': 'Percentage of participants with an event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '90 day', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': '12 month', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': '18 month', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': '24 month', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': '30 month', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': '36 month', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': '42 month', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.', 'unitOfMeasure': 'Percentage of participants with an event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Death or Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '90 Days', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': '42 months', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.', 'unitOfMeasure': 'Percentage of participants with an event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Major Complications From Cardiovascular (CV) Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '90 day', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': '12 month', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': '18 month', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': '24 month', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': '30 month', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': '36 month', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': '42 month', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.', 'unitOfMeasure': 'Percentage of participants with an event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '90 days', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': '42 months', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.', 'unitOfMeasure': 'Percentage of participants with an event', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 90 days following participant randomization', 'description': 'Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization', 'unitOfMeasure': 'Percentage of events', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4818', 'groupId': 'OG000'}, {'value': '4831', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '90 days', 'categories': [{'measurements': [{'value': '2494', 'groupId': 'OG000', 'lowerLimit': '2233', 'upperLimit': '2821'}, {'value': '2240', 'groupId': 'OG001', 'lowerLimit': '1599', 'upperLimit': '3119'}]}]}, {'title': '3 years cumulative', 'categories': [{'measurements': [{'value': '7213', 'groupId': 'OG000', 'lowerLimit': '6501', 'upperLimit': '8156'}, {'value': '6586', 'groupId': 'OG001', 'lowerLimit': '5683', 'upperLimit': '7772'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days and 3 years cumulative', 'description': 'Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.', 'unitOfMeasure': 'Per participant cost in US dollars', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by Duke Activity Status Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2982', 'groupId': 'OG000'}, {'value': '3003', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '38.2'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '39.5'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '44.7'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '44.7'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '44.7'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '44.7'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '45.5'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '45.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 12 months 24 months', 'description': "Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).", 'unitOfMeasure': 'participant score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants were limited due to budget constraints.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2982', 'groupId': 'OG000'}, {'value': '3003', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '90'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': '12 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': '24 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 month, 12 month, 24 month', 'description': 'Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \\& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \\& less frequent, condition has less impact on activities, increased satisfaction with treatment, \\& perception of disease has less impact on interpersonal relationships.', 'unitOfMeasure': 'participant score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants were limited due to budget constraints.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2982', 'groupId': 'OG000'}, {'value': '3003', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '75.0'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '41.7', 'upperLimit': '75.0'}]}]}, {'title': '6 month', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '91.7'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '100'}]}]}, {'title': '12 month', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '100'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '100'}]}]}, {'title': '24 month', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, 12 months, 24 months', 'description': 'Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \\& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \\& less frequent, condition has less impact on activities, increased satisfaction with treatment, \\& perception of disease has less impact on interpersonal relationships.', 'unitOfMeasure': 'participant score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants were limited due to budget constraints.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2982', 'groupId': 'OG000'}, {'value': '3003', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month, 12 month 24 month', 'description': 'Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants were limited due to budget constraints.'}, {'type': 'SECONDARY', 'title': 'Cumulative Radiation Exposure Within 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4996', 'groupId': 'OG000'}, {'value': '5007', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'OG001', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '17.2'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days', 'description': 'Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.', 'unitOfMeasure': 'milliSievert (mSv)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}, {'id': 'FG001', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5007'}, {'groupId': 'FG001', 'numSubjects': '4996'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3737'}, {'groupId': 'FG001', 'numSubjects': '4123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1270'}, {'groupId': 'FG001', 'numSubjects': '873'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '652'}, {'groupId': 'FG001', 'numSubjects': '510'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '543'}, {'groupId': 'FG001', 'numSubjects': '289'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5007', 'groupId': 'BG000'}, {'value': '4996', 'groupId': 'BG001'}, {'value': '10003', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Functional Diagnostic Tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram\n\nStress Echocardiogram: Use of standard equipment for usual-care testing\n\nNuclear Stress Test: Use of standard equipment for usual-care testing\n\nExercise Electrocardiogram: Use of standard equipment for usual-care testing'}, {'id': 'BG001', 'title': 'Anatomic Diagnostic Test', 'description': 'Coronary Angiography\n\nCoronary Angiography: Use of standard equipment for usual-care testing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2675', 'groupId': 'BG000'}, {'value': '2595', 'groupId': 'BG001'}, {'value': '5270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2332', 'groupId': 'BG000'}, {'value': '2401', 'groupId': 'BG001'}, {'value': '4733', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10003}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2010-08-02', 'resultsFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2010-08-02', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-02', 'studyFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Primary Endpoint', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.'}], 'secondaryOutcomes': [{'measure': 'Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.'}, {'measure': 'Time to Death or Myocardial Infarction (MI)', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.'}, {'measure': 'Time to Major Complications From Cardiovascular (CV) Procedures', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.'}, {'measure': 'Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)', 'timeFrame': '90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months', 'description': 'Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.'}, {'measure': 'Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization', 'timeFrame': 'Up to 90 days following participant randomization', 'description': 'Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization'}, {'measure': 'Medical Cost', 'timeFrame': '90 days and 3 years cumulative', 'description': 'Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.'}, {'measure': 'Quality of Life (QOL) as Measured by Duke Activity Status Index', 'timeFrame': 'Baseline, 6 months, 12 months 24 months', 'description': "Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity)."}, {'measure': 'Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale', 'timeFrame': 'Baseline, 6 month, 12 month, 24 month', 'description': 'Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \\& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \\& less frequent, condition has less impact on activities, increased satisfaction with treatment, \\& perception of disease has less impact on interpersonal relationships.'}, {'measure': 'Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale', 'timeFrame': 'Baseline, 6 months, 12 months, 24 months', 'description': 'Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning \\& summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable \\& less frequent, condition has less impact on activities, increased satisfaction with treatment, \\& perception of disease has less impact on interpersonal relationships.'}, {'measure': 'Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing', 'timeFrame': '6 month, 12 month 24 month', 'description': 'Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing'}, {'measure': 'Cumulative Radiation Exposure Within 90 Days', 'timeFrame': '90 days', 'description': 'Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chest pain', 'coronary artery disease', 'CAD'], 'conditions': ['Chest Pain']}, 'referencesModule': {'references': [{'pmid': '40864459', 'type': 'DERIVED', 'citation': 'Douglas PS, Stebbins A, Foldyna B, Patel MR, Mark DB, Lu MT, Hoffmann U, Shah SH, Martinez B, Alhanti B, Pagidipati N. Survival After Initial Stress Testing vs Anatomic Testing in Suspected Coronary Artery Disease: Long-Term Follow-Up of the PROMISE Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 1;10(10):1050-1054. doi: 10.1001/jamacardio.2025.2882.'}, {'pmid': '40590244', 'type': 'DERIVED', 'citation': 'Rasmussen LD, Sikjaer M, Soby JH, Pedersen OB, Westra J, Efthekhari A, Christiansen EH, Foldyna B, Williams MC, Dweck MR, Newby DE, Douglas PS, Bottcher M, Winther S. Dual probability approach for risk adjustment in patients with a low clinical likelihood of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2025 Aug 29;26(9):1507-1517. doi: 10.1093/ehjci/jeaf193.'}, {'pmid': '36565187', 'type': 'DERIVED', 'citation': 'McGarrah RW, Ferencik M, Giamberardino SN, Hoffmann U, Foldyna B, Karady J, Ginsburg GS, Kraus WE, Douglas PS, Shah SH. Lipoprotein Subclasses Associated With High-Risk Coronary Atherosclerotic Plaque: Insights From the PROMISE Clinical Trial. J Am Heart Assoc. 2023 Jan 3;12(1):e026662. doi: 10.1161/JAHA.122.026662. Epub 2022 Dec 24.'}, {'pmid': '36281983', 'type': 'DERIVED', 'citation': 'Karady J, Ferencik M, Mayrhofer T, Meyersohn NM, Bittner DO, Staziaki PV, Szilveszter B, Hallett TR, Lu MT, Puchner SB, Simon TG, Foldyna B, Ginsburg GS, McGarrah RW, Voora D, Shah SH, Douglas PS, Hoffmann U, Corey KE. Risk factors for cardiovascular disease among individuals with hepatic steatosis. Hepatol Commun. 2022 Dec;6(12):3406-3420. doi: 10.1002/hep4.2090. Epub 2022 Oct 25.'}, {'pmid': '35926901', 'type': 'DERIVED', 'citation': 'Ferencik M, Mayrhofer T, Lu MT, Bittner DO, Emami H, Puchner SB, Meyersohn NM, Ivanov AV, Adami EC, Voora D, Ginsburg GS, Januzzi JL, Douglas PS, Hoffmann U. Coronary Atherosclerosis, Cardiac Troponin, and Interleukin-6 in Patients With Chest Pain: The PROMISE Trial Results. JACC Cardiovasc Imaging. 2022 Aug;15(8):1427-1438. doi: 10.1016/j.jcmg.2022.03.016. Epub 2022 May 11.'}, {'pmid': '35369715', 'type': 'DERIVED', 'citation': 'Lowenstern A, Alexander KP, Pagidipati NJ, Hill CL, Pellikka PA, Cooper LS, Alhanti B, Hoffmann U, Mark DB, Douglas PS. Presenting Symptoms in Patients Undergoing Coronary Artery Disease Evaluation: Association With Noninvasive Test Results and Clinical Outcomes in the PROMISE Trial. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008298. doi: 10.1161/CIRCOUTCOMES.121.008298. Epub 2022 Apr 4.'}, {'pmid': '35110385', 'type': 'DERIVED', 'citation': 'Fordyce CB, Hill CL, Mark DB, Alhanti B, Pellikka PA, Hoffmann U, Patel MR, Douglas PS; PROMISE Investigators. Physician judgement in predicting obstructive coronary artery disease and adverse events in chest pain patients. Heart. 2022 May 12;108(11):860-867. doi: 10.1136/heartjnl-2021-320275.'}, {'pmid': '33558267', 'type': 'DERIVED', 'citation': 'Kammerlander AA, Mayrhofer T, Ferencik M, Pagidipati NJ, Karady J, Ginsburg GS, Lu MT, Bittner DO, Puchner SB, Bihlmeyer NA, Meyersohn NM, Emami H, Shah SH, Douglas PS, Hoffmann U; PROMISE Investigators. Association of Metabolic Phenotypes With Coronary Artery Disease and Cardiovascular Events in Patients With Stable Chest Pain. Diabetes Care. 2021 Apr;44(4):1038-1045. doi: 10.2337/dc20-1760. Epub 2021 Feb 8.'}, {'pmid': '32707340', 'type': 'DERIVED', 'citation': 'Meyersohn NM, Mayrhofer T, Corey KE, Bittner DO, Staziaki PV, Szilveszter B, Hallett T, Lu MT, Puchner SB, Simon TG, Foldyna B, Voora D, Ginsburg GS, Douglas PS, Hoffmann U, Ferencik M. Association of Hepatic Steatosis With Major Adverse Cardiovascular Events, Independent of Coronary Artery Disease. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1480-1488.e14. doi: 10.1016/j.cgh.2020.07.030. Epub 2020 Jul 21.'}, {'pmid': '32268807', 'type': 'DERIVED', 'citation': 'Goyal A, Pagidipati N, Hill CL, Alhanti B, Udelson JE, Picard MH, Pellikka PA, Hoffmann U, Mark DB, Douglas PS. Clinical and Economic Implications of Inconclusive Noninvasive Test Results in Stable Patients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial. Circ Cardiovasc Imaging. 2020 Apr;13(4):e009986. doi: 10.1161/CIRCIMAGING.119.009986. Epub 2020 Apr 9.'}, {'pmid': '31738382', 'type': 'DERIVED', 'citation': 'Lowenstern A, Alexander KP, Hill CL, Alhanti B, Pellikka PA, Nanna MG, Mehta RH, Cooper LS, Bullock-Palmer RP, Hoffmann U, Douglas PS. Age-Related Differences in the Noninvasive Evaluation for Possible Coronary Artery Disease: Insights From the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Trial. JAMA Cardiol. 2020 Feb 1;5(2):193-201. doi: 10.1001/jamacardio.2019.4973.'}, {'pmid': '31601728', 'type': 'DERIVED', 'citation': 'Litwin SE, Coles A, Hill CL, Alhanti B, Pagidipati N, Lee KL, Pellikka PA, Mark DB, Udelson JE, Cooper L, Tardif JC, Hoffmann U, Douglas PS; PROMISE investigators. Discordances between predicted and actual risk in obese patients with suspected cardiac ischaemia. Heart. 2020 Feb;106(4):273-279. doi: 10.1136/heartjnl-2018-314503. Epub 2019 Oct 10.'}, {'pmid': '30954400', 'type': 'DERIVED', 'citation': 'Litwin SE, Coles A, Pagidipati N, Lee KL, Pellikka PA, Mark DB, Udelson JE, Hoffmann U, Douglas PS; PROMISE Investigators. Effects of obesity on noninvasive test results in patients with suspected cardiac ischemia: Insights from the PROMISE trial. J Cardiovasc Comput Tomogr. 2019 Jul-Aug;13(4):211-218. doi: 10.1016/j.jcct.2019.03.010. Epub 2019 Mar 27.'}, {'pmid': '30819356', 'type': 'DERIVED', 'citation': 'Sharma A, Coles A, Sekaran NK, Pagidipati NJ, Lu MT, Mark DB, Lee KL, Al-Khalidi HR, Hoffmann U, Douglas PS. Stress Testing Versus CT Angiography in Patients With Diabetes and Suspected Coronary Artery Disease. J Am Coll Cardiol. 2019 Mar 5;73(8):893-902. doi: 10.1016/j.jacc.2018.11.056.'}, {'pmid': '30712364', 'type': 'DERIVED', 'citation': 'Jang JJ, Bhapkar M, Coles A, Vemulapalli S, Fordyce CB, Lee KL, Udelson JE, Hoffmann U, Tardif JC, Jones WS, Mark DB, Sorrell VL, Espinoza A, Douglas PS, Patel MR; PROMISE Investigators. Predictive Model for High-Risk Coronary Artery Disease. Circ Cardiovasc Imaging. 2019 Feb;12(2):e007940. doi: 10.1161/CIRCIMAGING.118.007940.'}, {'pmid': '30678753', 'type': 'DERIVED', 'citation': 'Januzzi JL Jr, Suchindran S, Hoffmann U, Patel MR, Ferencik M, Coles A, Tardif JC, Ginsburg GS, Douglas PS; PROMISE Investigators. Single-Molecule hsTnI and Short-Term Risk in Stable Patients With Chest Pain. J Am Coll Cardiol. 2019 Jan 29;73(3):251-260. doi: 10.1016/j.jacc.2018.10.065.'}, {'pmid': '30529930', 'type': 'DERIVED', 'citation': 'Pagidipati NJ, Coles A, Hemal K, Lee KL, Dolor RJ, Pellikka PA, Mark DB, Patel MR, Litwin SE, Daubert MA, Shah SH, Hoffmann U, Douglas PS; PROMISE Investigators. Sex differences in management and outcomes of patients with stable symptoms suggestive of coronary artery disease: Insights from the PROMISE trial. Am Heart J. 2019 Feb;208:28-36. doi: 10.1016/j.ahj.2018.11.002. Epub 2018 Nov 9.'}, {'pmid': '30190030', 'type': 'DERIVED', 'citation': 'Adamson PD, Newby DE, Hill CL, Coles A, Douglas PS, Fordyce CB. Comparison of International Guidelines for Assessment of Suspected Stable Angina: Insights From the PROMISE and SCOT-HEART. JACC Cardiovasc Imaging. 2018 Sep;11(9):1301-1310. doi: 10.1016/j.jcmg.2018.06.021.'}, {'pmid': '29550314', 'type': 'DERIVED', 'citation': 'Januzzi JL Jr, Suchindran S, Coles A, Ferencik M, Patel MR, Hoffmann U, Ginsburg GS, Douglas PS; PROMISE Investigators. High-Sensitivity Troponin I and Coronary Computed Tomography in Symptomatic Outpatients With Suspected CAD: Insights From the PROMISE Trial. JACC Cardiovasc Imaging. 2019 Jun;12(6):1047-1055. doi: 10.1016/j.jcmg.2018.01.021. Epub 2018 Mar 14.'}, {'pmid': '29322167', 'type': 'DERIVED', 'citation': 'Ferencik M, Mayrhofer T, Bittner DO, Emami H, Puchner SB, Lu MT, Meyersohn NM, Ivanov AV, Adami EC, Patel MR, Mark DB, Udelson JE, Lee KL, Douglas PS, Hoffmann U. Use of High-Risk Coronary Atherosclerotic Plaque Detection for Risk Stratification of Patients With Stable Chest Pain: A Secondary Analysis of the PROMISE Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):144-152. doi: 10.1001/jamacardio.2017.4973.'}, {'pmid': '29178815', 'type': 'DERIVED', 'citation': 'Lu MT, Meyersohn NM, Mayrhofer T, Bittner DO, Emami H, Puchner SB, Foldyna B, Mueller ME, Hearne S, Yang C, Achenbach S, Truong QA, Ghoshhajra BB, Patel MR, Ferencik M, Douglas PS, Hoffmann U. Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial. Radiology. 2018 Apr;287(1):87-95. doi: 10.1148/radiol.2017172181. Epub 2017 Nov 27.'}, {'pmid': '29089344', 'type': 'DERIVED', 'citation': 'Sharma A, Sekaran NK, Coles A, Pagidipati NJ, Hoffmann U, Mark DB, Lee KL, Al-Khalidi HR, Lu MT, Pellikka PA, Truong QA, Douglas PS. Impact of Diabetes Mellitus on the Evaluation of Stable Chest Pain Patients: Insights From the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Trial. J Am Heart Assoc. 2017 Oct 31;6(11):e007019. doi: 10.1161/JAHA.117.007019.'}, {'pmid': '28965093', 'type': 'DERIVED', 'citation': 'Ladapo JA, Coles A, Dolor RJ, Mark DB, Cooper L, Lee KL, Goldberg J, Shapiro MD, Hoffmann U, Douglas PS. Quantifying sociodemographic and income disparities in medical therapy and lifestyle among symptomatic patients with suspected coronary artery disease: a cross-sectional study in North America. BMJ Open. 2017 Sep 29;7(9):e016364. doi: 10.1136/bmjopen-2017-016364.'}, {'pmid': '28847895', 'type': 'DERIVED', 'citation': 'Budoff MJ, Mayrhofer T, Ferencik M, Bittner D, Lee KL, Lu MT, Coles A, Jang J, Krishnam M, Douglas PS, Hoffmann U; PROMISE Investigators. Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Multicenter Imaging Study for Evaluation of Chest Pain). Circulation. 2017 Nov 21;136(21):1993-2005. doi: 10.1161/CIRCULATIONAHA.117.030578. Epub 2017 Aug 28.'}, {'pmid': '28838846', 'type': 'DERIVED', 'citation': 'Lu MT, Douglas PS, Udelson JE, Adami E, Ghoshhajra BB, Picard MH, Roberts R, Lee KL, Einstein AJ, Mark DB, Velazquez EJ, Carter W, Ridner M, Al-Khalidi HR, Hoffmann U. Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose. J Cardiovasc Comput Tomogr. 2017 Sep-Oct;11(5):373-382. doi: 10.1016/j.jcct.2017.08.005. Epub 2017 Aug 15.'}, {'pmid': '28389572', 'type': 'DERIVED', 'citation': 'Hoffmann U, Ferencik M, Udelson JE, Picard MH, Truong QA, Patel MR, Huang M, Pencina M, Mark DB, Heitner JF, Fordyce CB, Pellikka PA, Tardif JC, Budoff M, Nahhas G, Chow B, Kosinski AS, Lee KL, Douglas PS; PROMISE Investigators. Prognostic Value of Noninvasive Cardiovascular Testing in Patients With Stable Chest Pain: Insights From the PROMISE Trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain). Circulation. 2017 Jun 13;135(24):2320-2332. doi: 10.1161/CIRCULATIONAHA.116.024360. Epub 2017 Apr 7.'}, {'pmid': '28199464', 'type': 'DERIVED', 'citation': 'Fordyce CB, Douglas PS, Roberts RS, Hoffmann U, Al-Khalidi HR, Patel MR, Granger CB, Kostis J, Mark DB, Lee KL, Udelson JE; Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Investigators. Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2017 Apr 1;2(4):400-408. doi: 10.1001/jamacardio.2016.5501.'}, {'pmid': '27733347', 'type': 'DERIVED', 'citation': 'Ladapo JA, Hoffmann U, Lee KL, Coles A, Huang M, Mark DB, Dolor RJ, Pelberg RA, Budoff M, Sigurdsson G, Severance HW, Douglas PS. Changes in Medical Therapy and Lifestyle After Anatomical or Functional Testing for Coronary Artery Disease. J Am Heart Assoc. 2016 Oct 12;5(10):e003807. doi: 10.1161/JAHA.116.003807.'}, {'pmid': '27214597', 'type': 'DERIVED', 'citation': 'Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, Davidson-Ray L, Daniels MR, Cooper LS, Knight JD, Lee KL, Douglas PS; PROMISE Investigators. Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease. Ann Intern Med. 2016 Jul 19;165(2):94-102. doi: 10.7326/M15-2639. Epub 2016 May 24.'}, {'pmid': '27143676', 'type': 'DERIVED', 'citation': 'Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS; PROMISE Investigators. Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial. Circulation. 2016 May 24;133(21):1995-2007. doi: 10.1161/CIRCULATIONAHA.115.020259. Epub 2016 Apr 27.'}, {'pmid': '25773919', 'type': 'DERIVED', 'citation': 'Douglas PS, Hoffmann U, Patel MR, Mark DB, Al-Khalidi HR, Cavanaugh B, Cole J, Dolor RJ, Fordyce CB, Huang M, Khan MA, Kosinski AS, Krucoff MW, Malhotra V, Picard MH, Udelson JE, Velazquez EJ, Yow E, Cooper LS, Lee KL; PROMISE Investigators. Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med. 2015 Apr 2;372(14):1291-300. doi: 10.1056/NEJMoa1415516. Epub 2015 Mar 14.'}, {'pmid': '24890527', 'type': 'DERIVED', 'citation': 'Douglas PS, Hoffmann U, Lee KL, Mark DB, Al-Khalidi HR, Anstrom K, Dolor RJ, Kosinski A, Krucoff MW, Mudrick DW, Patel MR, Picard MH, Udelson JE, Velazquez EJ, Cooper L; PROMISE investigators. PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial. Am Heart J. 2014 Jun;167(6):796-803.e1. doi: 10.1016/j.ahj.2014.03.003. Epub 2014 Mar 18.'}], 'seeAlsoLinks': [{'url': 'http://www.promisetrial.org', 'label': 'PROMISE trial web site'}]}, 'descriptionModule': {'briefSummary': 'A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.', 'detailedDescription': "Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)\n* no prior evaluation for this episode of symptoms\n* planned non-invasive testing for diagnosis\n* men age ≥55 years\n* men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \\>50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented \\> 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than \\<0.9, 4-Dyslipidemia\n* women age ≥65 years\n* women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \\>50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented \\> 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than \\<0.9, 4-Dyslipidemia\n* Serum creatinine ≤ 1.5 mg/dL within the past 90 days\n* Negative urine/serum pregnancy test for female subjects of child-bearing potential\n\nExclusion Criteria:\n\n* Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)\n* Hemodynamically or clinically unstable condition systolic blood pressure (BP) \\< 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)\n* Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel\n* Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months\n* Known significant congenital, valvular (\\> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms\n* Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate \\< 65 beats per minute, c. Pregnancy\n* Life expectancy \\< 2 years\n* Unable to provide written informed consent or participate in long-term follow-up'}, 'identificationModule': {'nctId': 'NCT01174550', 'acronym': 'PROMISE', 'briefTitle': 'PROspective Multicenter Imaging Study for Evaluation of Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial', 'orgStudyIdInfo': {'id': 'Pro00019865'}, 'secondaryIdInfos': [{'id': 'R01HL098237-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HL098237-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functional diagnostic tests', 'description': 'Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram', 'interventionNames': ['Procedure: Stress Echocardiogram', 'Procedure: Nuclear Stress Test', 'Procedure: Exercise Electrocardiogram']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anatomic diagnostic test', 'description': 'Coronary Angiography', 'interventionNames': ['Procedure: Coronary Angiography']}], 'interventions': [{'name': 'Coronary Angiography', 'type': 'PROCEDURE', 'description': 'Use of standard equipment for usual-care testing', 'armGroupLabels': ['Anatomic diagnostic test']}, {'name': 'Stress Echocardiogram', 'type': 'PROCEDURE', 'description': 'Use of standard equipment for usual-care testing', 'armGroupLabels': ['Functional diagnostic tests']}, {'name': 'Nuclear Stress Test', 'type': 'PROCEDURE', 'description': 'Use of standard equipment for usual-care testing', 'armGroupLabels': ['Functional diagnostic tests']}, {'name': 'Exercise Electrocardiogram', 'type': 'PROCEDURE', 'description': 'Use of standard equipment for usual-care testing', 'armGroupLabels': ['Functional diagnostic tests']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Pamela S Douglas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be submitted to the NHLBI according to their guidelines which state"The data sets must be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the PO for review prior to release."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}