Status:
ENROLLING_BY_INVITATION
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
Lead Sponsor:
MyOme
Collaborating Sponsors:
University of Pennsylvania
Mayo Clinic
Conditions:
Coronary Artery Disease
Polygenic Risk Score
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
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....
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
- No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
- Previously genotyped as part of a research study that enables recontact of participants
- Receiving primary care at a participating institution.
Exclusion
- Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
- Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
- Future use of statins contraindicated
- Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
- Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
- Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06542432
Start Date
January 1 2025
End Date
July 1 2029
Last Update
September 16 2025
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104