Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-01 @ 12:32 PM
Study NCT ID:
NCT01251302
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'PaxGene tube for RNA collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-11-30', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in management practice pattern between preliminary and after Corus CAD (ASGES) decision', 'timeFrame': 'Up to 7 days', 'description': 'Change in management pattern comparing the preliminary and after Corus CAD (ASGES) decision will be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:\n\n1. No further cardiac testing or treatment\n2. Medical therapy for angina or non-cardiac chest pain\n3. Stress testing with or without imaging\n4. CT angiography\n5. Invasive cardiac catheterization'}, {'measure': 'Change in management practice pattern between after Corus CAD decision and historical cohort.', 'timeFrame': 'up to 195 days', 'description': 'Change in management pattern comparing the Corus CAD (ASGES) driven decision and the historical cohort ill be measured by the number of subjects with medical management downgrade or upgrade within the following predefined categories:\n\n1. No further cardiac testing or treatment\n2. Medical therapy for angina or non-cardiac chest pain\n3. Stress testing with or without imaging\n4. CT angiography\n5. Invasive cardiac catheterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Corus CAD', 'Age/Sex/Gene Expression Score', 'Molecular Genetics', 'Atherosclerosis', 'ASGES', 'Gene Expression', 'GES', 'CAD', 'CVD', 'CHD', 'Clinical Utility', 'Precision Medicine', 'Coronary Artery Disease', 'Angina Pectoris', 'Chest Pain', 'Cardiovascular Disease', 'Coronary Heart Disease', 'IMPACT', 'IMPACT-CARD'], 'conditions': ['Angina Pectoris', 'Coronary Artery Disease', 'Chest Pain', 'Cardiovascular Diseases', 'Coronary Heart Disease', 'CAD', 'CVD', 'CHD']}, 'referencesModule': {'references': [{'pmid': '23680805', 'type': 'RESULT', 'citation': 'McPherson JA, Davis K, Yau M, Beineke P, Rosenberg S, Monane M, Fredi JL. The clinical utility of gene expression testing on the diagnostic evaluation of patients presenting to the cardiologist with symptoms of suspected obstructive coronary artery disease: results from the IMPACT (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial. Crit Pathw Cardiol. 2013 Jun;12(2):37-42. doi: 10.1097/HPC.0b013e3182822bd0.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay changes the diagnostic testing pattern in patients referred to a cardiologist for the evaluation of chest pain or anginal equivalent symptoms.', 'detailedDescription': 'A prospective cohort of 88 subjects receiving the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay were compared to a retrospective cohort of 83 subjects that did not receive the assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll a patient population that present with chest pain or anginal equivalent symptoms who are referred to a cardiologist for evaluation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stable chest pain, typical or atypical angina or anginal equivalent\n2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.\n\nExclusion Criteria:\n\n1. History of myocardial infarction\n2. Current myocardial infarct (MI) or acute coronary syndrome\n3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms\n4. Any previous coronary revascularization\n5. Any individuals with:\n\n 1. Diabetes\n 2. Suspected unstable angina\n 3. Systemic infections\n 4. Systemic inflammatory conditions\n6. Any individuals currently taking:\n\n 1. Steroids\n 2. Immunosuppressive agents\n 3. Chemotherapeutic agents\n7. Recipient of any organ transplant'}, 'identificationModule': {'nctId': 'NCT01251302', 'acronym': 'IMPACT-CARD', 'briefTitle': 'Utility of a Molecular Personalized Coronary Gene Expression Test (Corus CAD or ASGES) on Cardiology Practice Pattern', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioDx'}, 'officialTitle': 'Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern', 'orgStudyIdInfo': {'id': 'CDX_000011'}, 'secondaryIdInfos': [{'id': 'IMPACT-CARD', 'type': 'OTHER', 'domain': 'CardioDx'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective Cohort', 'description': 'Patient presenting with chest pain or anginal equivalent and receiving a resulted age, sex and gene expression score (ASGES) to assist in diagnosis.', 'interventionNames': ['Diagnostic Test: Corus CAD (ASGES)']}, {'label': 'Retrospective Cohort', 'description': 'Patients presenting with chest pain or anginal equivalent who did not receive an age, sex and gene expression score (ASGES) to assist in diagnosis. Note: this cohort was historical.'}], 'interventions': [{'name': 'Corus CAD (ASGES)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Age/Sex/Gene Expression Score - ASGES', 'armGroupLabels': ['Prospective Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Michael Zapien, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CardioDx, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioDx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}