Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-31 @ 12:41 PM
Study NCT ID:
NCT00933400
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2009-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D004630', 'term': 'Emergencies'}], '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': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072226', 'term': 'Computed Tomography Angiography'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nfredericks@acr.org', 'phone': '215-574-3150', 'title': 'Communications Director', 'organization': 'American College of Radiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'within 30 days of study scan and at 1 year follow up (or study termination visit if occurring prior to 1 year follow up)', 'description': 'Adverse events were assessed via record review, patient and secondary contacts, and the Social Security Death Master File was consulted for vital status (date last accessed for all patients, January 25, 2012).', 'eventGroups': [{'id': 'EG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" (Group B)', 'description': 'Participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.', 'otherNumAtRisk': 929, 'deathsNumAtRisk': 929, 'otherNumAffected': 0, 'seriousNumAtRisk': 929, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.", 'otherNumAtRisk': 463, 'deathsNumAtRisk': 463, 'otherNumAffected': 0, 'seriousNumAtRisk': 463, 'deathsNumAffected': 3, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'General disorders and administration site conditions (death)', 'notes': '10011914 - self-inflicted gunshot wound to the head (per Death certificate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': '10040741 - Sinus Bradycardia', 'notes': 'Pt had a CCTA as part of the usual care arm. Unclear whether bradycardia was result of IV dye or beta- blocker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 929, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}, {'value': '640', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CT Coronary Angiography (Group B)', 'description': 'Participants randomized to CT coronary angiography with scan planned as soon as the CT scanner is available following the initial values assessment (expected within 90 minutes). Participants with negative test results will be discharged unless other indications for admission per standard of care. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography was performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test was considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results were communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management.'}, {'id': 'OG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department."}, {'id': 'OG002', 'title': 'Negative CT Coronary Angiography-based Rapid "Rule Out" (Group B)', 'description': 'This group contains only those subjects from Group B where the imaging test was completed and negative: the participant had a \\<= 50% stenosis of the right coronary, left main, left anterior descending, and circumflex arteries and of their branches in contrast-enhanced CT coronary angiography.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AMI', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '5.7', 'groupDescription': 'Difference in AMI rate. NULL: equal rates of AMI in both Groups.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'equivalence margin = 0'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days of discharge from the ED', 'description': 'To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days of discharge from Emergency Department (ED) - patient follow-up included telephone interviews 30 days and 1 year after triage/presentation.\n\nParticipants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography were considered negative and considered discharged if they were not designated to receive an inpatient bed or formal observation status.\n\nAll myocardial infarctions were reviewed by an Adjudication Committee to confirm diagnosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" (Group B)', 'description': 'Participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.'}, {'id': 'OG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department."}], 'classes': [{'title': 'Discharge from ED', 'categories': [{'measurements': [{'value': '450', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Admission/observation to ED', 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}]}, {'title': 'Significant coronary disease', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (rates)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.8', 'ciLowerLimit': '21.4', 'ciUpperLimit': '32.2', 'groupDescription': 'Difference in Discharge rates. H0: equal rates of Discharge in both Groups.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'equivalence margin = 0'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference (percents)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '0.0', 'ciUpperLimit': '11.2', 'estimateComment': 'exact procedures were used to estimate and compare rates of detection for significant coronary disease', 'groupDescription': 'Difference in diagnosis rate of Significant coronary disease at index visit. H0: equal rates in both Groups.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'equivalence margin = 0'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': 'The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Length of Hospital Stay After Initial Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" (Group B)', 'description': 'Participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.'}, {'id': 'OG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department."}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '27.2'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '30.5'}]}]}, {'title': 'Subjects with negative test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '24.3'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': '29.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-7 days', 'description': 'Compare the length of hospital stay in hours between the groups', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Results report for all patient and for those with a negative index visit assessment.'}, {'type': 'SECONDARY', 'title': 'Health Care Utilization During the Index Hospitalization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" (Group B)', 'description': 'Participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.'}, {'id': 'OG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department."}], 'classes': [{'title': 'CCTA', 'categories': [{'measurements': [{'value': '767', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Stress testing, with or without imaging', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac catheterization', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'No additional Diagnostic tests', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}, {'title': 'Hosp. Admission or observation', 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.8', 'ciLowerLimit': '21.4', 'ciUpperLimit': '32.2', 'estimateComment': 'Exact confidence intervals for the difference in proportions', 'groupDescription': 'H0: no difference in Patient disposition (Discharge) rates between arms', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-7 Days', 'description': 'Downstream diagnostic test during the index visit including Hospital admission or observation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Health Care Utilization 1 Year Post Triage/Presentation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" Arm (Group B)', 'description': 'Participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.'}, {'id': 'OG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department."}], 'classes': [{'title': 'Emergency department visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '305', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}, {'title': 'Hospital admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Cardiologist office visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'CCTA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Stress testing without imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Stress testing with imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '829', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 1-yr study follow up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with index visit and know outcome at 1-yr post ED triage'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" (Group B)', 'description': 'Participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography: CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.'}, {'id': 'OG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department."}], 'classes': [{'title': 'All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '906', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '872', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '5.2', 'estimateComment': 'Exact confidence intervals for the difference in proportions', 'groupDescription': 'Compare all cause mortality between groups', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '5.7', 'estimateComment': 'Exact confidence intervals for the difference in proportions', 'groupDescription': 'Compare Cardiac Death between groups', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '5.9', 'estimateComment': 'Exact confidence intervals for the difference in proportions', 'groupDescription': 'Compare AMI between groups', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '03', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '6.0', 'estimateComment': 'Exact confidence intervals for the difference in proportions', 'groupDescription': 'Compare MACE between groups', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '7.0', 'estimateComment': 'Exact confidence intervals for the difference in proportions', 'groupDescription': 'Compare Revascularization between groups', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 1-yr study follow up', 'description': 'MACE at 1 year was determined by Patient telephone contact Medical record review Records at the presenting and neighboring hospitals were reviewed for repeat visits When these methods failed to provide survival information, we searched the Social Security Death Master File', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject with index visit, Vital status available at 1-yr post ED triage, and known outcome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT Coronary Angiography (Group B:CCTA)', 'description': 'In the study Coronary computed tomographic angiography (CCTA) -based rapid "rule out" arm (Group B), participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.'}, {'id': 'FG001', 'title': 'Traditional Strategy (Group A)', 'description': 'In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '929'}, {'groupId': 'FG001', 'numSubjects': '463'}]}, {'type': 'Index Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '908'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'CCTA Performed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '767'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Vital Status Available 30 Days Post ED Triage', 'achievements': [{'groupId': 'FG000', 'numSubjects': '908'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': '30 Day Post ED Triage Follow-up Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '898'}, {'groupId': 'FG001', 'numSubjects': '457'}]}, {'type': '1-year Post ED Triage Follow-up Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '907'}, {'groupId': 'FG001', 'numSubjects': '461'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '908'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study recruited patients presenting to the emergency department (ED) with potential acute coronary syndromes. After the initial electrocardiogram, consenting subjects were randomization to CCTA or traditional care (2:1ratio). Subjects subsequently found to have a creatinine clearance less than 60 ml/minute or who received a pulmonary embolism protocol CT rather than a CCTA were removed from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'BG000'}, {'value': '462', 'groupId': 'BG001'}, {'value': '1370', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CT Coronary Angiography-based Rapid "Rule Out" Arm (Group B)', 'description': 'Participants receive initial cardiac troponin/creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), participants receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.\n\nCT Coronary Angiography(CTCA): CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible Emergency Department (ED) and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.'}, {'id': 'BG001', 'title': 'Traditional Strategy (Group A)', 'description': "In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.\n\nTraditional Strategy: Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care (SOC) procedures in the institution's emergency department (ED)."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '50', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '49', 'spread': '9.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '443', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '465', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '867', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '1306', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '520', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '806', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiac history and risk factors', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '463', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '695', 'groupId': 'BG002'}]}]}, {'title': 'Hypercholesterolemia', 'categories': [{'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}, {'title': 'Family History of CAD', 'categories': [{'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes Mellitus', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}, {'title': 'Current Tobacco use', 'categories': [{'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}, {'title': 'Cocaine use in last week', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Heart failure', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Values represent the number of participants presenting with the specified condition', 'unitOfMeasure': 'Participants'}, {'title': 'Presenting electrocardiogram', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '584', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '883', 'groupId': 'BG002'}]}]}, {'title': 'Nonspecific', 'categories': [{'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}, {'title': 'Early repolarization', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Non-diagnostic', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Ischemia (inadequate blood supply) known to be old', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Ischemia (inadequate blood supply) not known to be old', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'ST Elevation consistent with Acute Myocardial Infarction (AMI)-old', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other/Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization occurred after an initial electrocardiogram and results (Normal v non-normal) are presented here', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-03-10', 'size': 590107, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-08-25T14:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2009-07-02', 'resultsFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-09', 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days', 'timeFrame': 'up to 30 days of discharge from the ED', 'description': 'To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days of discharge from Emergency Department (ED) - patient follow-up included telephone interviews 30 days and 1 year after triage/presentation.\n\nParticipants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography were considered negative and considered discharged if they were not designated to receive an inpatient bed or formal observation status.\n\nAll myocardial infarctions were reviewed by an Adjudication Committee to confirm diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.', 'timeFrame': 'baseline', 'description': 'The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.'}, {'measure': 'Mean Length of Hospital Stay After Initial Visit', 'timeFrame': '1-7 days', 'description': 'Compare the length of hospital stay in hours between the groups'}, {'measure': 'Health Care Utilization During the Index Hospitalization.', 'timeFrame': '1-7 Days', 'description': 'Downstream diagnostic test during the index visit including Hospital admission or observation.'}, {'measure': 'Cardiac Health Care Utilization 1 Year Post Triage/Presentation.', 'timeFrame': 'Through 1-yr study follow up'}, {'measure': 'Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation', 'timeFrame': 'Through 1-yr study follow up', 'description': 'MACE at 1 year was determined by Patient telephone contact Medical record review Records at the presenting and neighboring hospitals were reviewed for repeat visits When these methods failed to provide survival information, we searched the Social Security Death Master File'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Computed Tomography', 'CT Angiography (CTA)', 'Cardiac CT', 'CT', 'Cardiac CTA (CCTA)', 'Chest Pain', 'Heart Attack', 'Emergency Department', 'Myocardial Infarction', 'Cost Effectiveness', 'Acute Coronary Event', 'Heart Imaging'], 'conditions': ['Chest Pain', 'Acute Coronary Syndrome', 'Acute Myocardial Infarction', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '28487318', 'type': 'DERIVED', 'citation': 'Bittner DO, Mayrhofer T, Bamberg F, Hallett TR, Janjua S, Addison D, Nagurney JT, Udelson JE, Lu MT, Truong QA, Woodard PK, Hollander JE, Miller C, Chang AM, Singh H, Litt H, Hoffmann U, Ferencik M. Impact of Coronary Calcification on Clinical Management in Patients With Acute Chest Pain. Circ Cardiovasc Imaging. 2017 May;10(5):e005893. doi: 10.1161/CIRCIMAGING.116.005893.'}, {'pmid': '22449295', 'type': 'DERIVED', 'citation': 'Litt HI, Gatsonis C, Snyder B, Singh H, Miller CD, Entrikin DW, Leaming JM, Gavin LJ, Pacella CB, Hollander JE. CT angiography for safe discharge of patients with possible acute coronary syndromes. N Engl J Med. 2012 Apr 12;366(15):1393-403. doi: 10.1056/NEJMoa1201163. Epub 2012 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'This multi-center, randomized, controlled trial conducted in Emergency Departments (ED) compares computed tomography (CT) coronary angiography with the traditional approach (usual care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography. Additional evaluations will comprise health care utilization assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year post-triage/presentation major cardiac event rates.', 'detailedDescription': 'In this study, participants with potential ACS will be randomized to traditional "rule out" care (Group A) or to traditional care plus CT coronary angiography (Group B) in a ratio of 1:2 traditional versus traditional plus CT coronary angiography.\n\nIn Group A, all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will be admitted to hospital, admitted to cardiac diagnostic unit, or discharged to home. Diagnostic testing and treatment will be decided by the team caring for the participant. Follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation.\n\nIn Group B, participants will receive initial cardiac troponin and creatinine blood tests. Upon return of normal laboratory values, the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available. Participants with negative test results will be discharged; follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation. Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is 30 years of age or older\n* Participant presents with complaints consistent with potential ACS (e.g., chest pain, shortness of breath, other)\n* Participant requires admission or objective testing to exclude ACS\n* Participant with initial ECG result without acute ischemia\n* Participant with an initial Thrombolysis in Myocardial Infarction (TIMI) Risk Score of 0 to 2\n* Participant is willing to provide a written informed consent\n\nExclusion Criteria:\n\n* Patients who present with symptoms that are clearly not cardiac in origin (e.g., chest pain secondary to herpes zoster, obvious pneumonia, or recent trauma);\n* Patients with no initial ECG performed in the ED\n* Patients with ST-elevation myocardial infarction (STEMI)\n* Patients with existing co-morbidity that requires admission regardless of presence of ACS (e.g., uncontrolled diabetes)\n* Patients with known contraindications to CT coronary angiography: Iodinated contrast allergic-like reaction\n* Patients who are known to have had CT coronary angiography in the year prior to presentation\n* Patients who are known to have normal catheterization results (no or minimal, \\< 25%, stenosis) in the year prior to presentation\n* Patients who are pregnant\n* Patients with known renal insufficiency (e.g., creatinine clearance \\< 60 mL/min/1.73 m2)\n* Patients with no telephone or cell phone numbers (preventing follow up)\n* Patients unwilling to provide a written informed consent'}, 'identificationModule': {'nctId': 'NCT00933400', 'briefTitle': 'Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)', 'organization': {'class': 'OTHER', 'fullName': 'American College of Radiology'}, 'officialTitle': 'Randomized Controlled Study of a Rapid "Rule Out" Strategy Using Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care for Low- to Intermediate-Risk Emergency Department (ED) Patients With Potential Acute Coronary Syndromes (ACS)', 'orgStudyIdInfo': {'id': 'ACRIN PA 4005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Strategy [Group A]', 'description': 'In the traditional-care arm (Group A:Standard of Care (SOC)), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.', 'interventionNames': ['Procedure: Traditional Strategy']}, {'type': 'EXPERIMENTAL', 'label': 'CT Coronary Angiography (CTCA)[Group B]', 'description': 'In the study CT coronary angiography-based rapid "rule out" arm (Group B), participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.', 'interventionNames': ['Diagnostic Test: CT Coronary Angiography (CTCA)']}], 'interventions': [{'name': 'CT Coronary Angiography (CTCA)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CT angiography (CTA)', 'CTCA'], 'description': 'CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.', 'armGroupLabels': ['CT Coronary Angiography (CTCA)[Group B]']}, {'name': 'Traditional Strategy', 'type': 'PROCEDURE', 'otherNames': ['Standard of Care (SOC)', 'Traditional, Standard of Care', 'Routine Care'], 'description': "Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.", 'armGroupLabels': ['Traditional Strategy [Group A]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey - Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn-Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Harold I Litt, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pennsylvania Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American College of Radiology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pennsylvania Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}