Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-02 @ 10:03 AM
Study NCT ID:
NCT06542432
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-16
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000096442', 'term': 'Genetic Risk Score'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing?", 'timeFrame': '5 years', 'description': 'Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group.'}, {'measure': 'Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?', 'timeFrame': '5 years', 'description': 'Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group.'}], 'secondaryOutcomes': [{'measure': 'Does the IRS identify those at elevated risk for CAD and future ASCVD events?', 'timeFrame': '5 years', 'description': 'Aggregated longitudinal clinical data and patient survey data will be collected to compare patient clinical outcomes in those with a high CAD IRS.'}, {'measure': 'Does receiving an IRS report affect the incidence of CAD events?', 'timeFrame': '5 years', 'description': 'Aggregated longitudinal clinical data will be collected to compare patient clinical outcomes in those with a CAD IRS reported at baseline and the control group.'}, {'measure': 'Does receiving an IRS report affect participant understanding of their individual CAD risk?', 'timeFrame': '5 years', 'description': 'Patient survey data will be collected to assess their understanding of their CAD risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polygenic risk score', 'Integrated risk score', 'Genetics', 'Cardiovascular health', 'Coronary artery disease', 'Precision medicine'], 'conditions': ['Coronary Artery Disease', 'Polygenic Risk Score', 'Heart Diseases', 'Coronary Disease', 'Myocardial Infarction', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.", 'detailedDescription': 'This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations\n* No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)\n* Previously genotyped as part of a research study that enables recontact of participants\n* Receiving primary care at a participating institution.\n\nExclusion Criteria:\n\n* Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)\n* Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid\n* Future use of statins contraindicated\n* Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting\n* Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)\n* Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)'}, 'identificationModule': {'nctId': 'NCT06542432', 'briefTitle': 'Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MyOme'}, 'officialTitle': "A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)", 'orgStudyIdInfo': {'id': '004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention', 'description': 'Participants will receive their integrated risk score result for coronary artery disease.', 'interventionNames': ['Genetic: Disclosure of integrate risk score for coronary artery disease']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control', 'description': 'Participants will only receive standard of care ASCVD Pooled Cohorts Equation (ASCVD PCE), and disclosure of integrated risk score result will be deferred until 3 years after enrollment.'}], 'interventions': [{'name': 'Disclosure of integrate risk score for coronary artery disease', 'type': 'GENETIC', 'description': 'Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results.', 'armGroupLabels': ['Experimental: Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MyOme', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}