Trials / Enrolling By Invitation
Enrolling By InvitationNCT06542432
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)
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- MyOme · Industry
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
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. 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.
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 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.
Conditions
- Coronary Artery Disease
- Polygenic Risk Score
- Heart Diseases
- Coronary Disease
- Myocardial Infarction
- Cardiovascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Disclosure of integrate risk score for coronary artery disease | Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2029-07-01
- Completion
- 2029-07-01
- First posted
- 2024-08-07
- Last updated
- 2025-09-16
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06542432. Inclusion in this directory is not an endorsement.