NCT06542432Enrolling by invitation
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 29 Mar 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- MyOme
- Diseases
- Coronary artery disease
- NCT number
- NCT06542432
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 1 Jan 2025 to the primary completion date, 1 Jul 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
Lab values
- Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)
Other
- Future use of statins contraindicated
Who the study is looking for
- 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.
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.