Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
Purpose
The goal of this clinical trial is to evaluate whether disclosure of a polygenic risk score for coronary artery disease (CAD PRS) influences cardiovascular health and risk factor modification over one year among adults aged 30-75 years in the Mass General Brigham primary care network who are not currently taking LDL cholesterol-lowering medications.
Condition
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Between 30 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Current age 30-75 years - Established primary care at Mass General Brigham with at least one visit in the last 2 years
Exclusion Criteria
- Currently taking LDL cholesterol- lowering medications, including statins
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Single-center, parallel-group, randomized clinical trial with two arms: immediate disclosure of coronary artery disease polygenic risk score (CAD PRS) results versus deferred disclosure after approximately 12 months.
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Immediate Disclosure |
Participants are randomized to receive their CAD PRS results after genotyping. |
|
|
Active Comparator Deferred Disclosure |
Participants are randomized to have their CAD PRS results withheld until approximately 12 months after enrollment. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
The PROACT 3 clinical trial is designed to evaluate whether disclosure of a polygenic risk score for CAD PRS influences cardiovascular health and risk factor modification over one year. This is a single-center, randomized clinical trial conducted within the Mass General Brigham primary care network. Adults aged 30-75 years without cardiovascular disease and not currently taking LDL cholesterol-lowering medications will be identified through electronic health record queries. A total of 500 participants will be enrolled. All participants will undergo CAD PRS testing. Participants will then be randomized in a 1:1 ratio to one of two groups: an immediate disclosure group, in which participants receive their CAD PRS results, or a deferred disclosure group, in which results are returned after approximately 12 months. The primary outcome is the change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months. Secondary outcomes include change in cardiovascular health as measured by the American Heart Association's Life's Essential 8 (LE8) score, as well as measures of engagement with preventive care. These include completion of lipid panels and blood pressure measurements, attendance at primary care visits, and initiation of preventive therapies (including antihypertensive, lipid-lowering, or glucose-lowering therapies) when clinically indicated. Additional outcomes include changes in individual LE8 behavioral components (physical activity, diet, tobacco use, and sleep) and body mass index from baseline to 12 months. This trial will provide empirical evidence on the impact of disclosing CAD PRS results across the spectrum of genetic risk and will help inform best practices for the integration of polygenic risk information into preventive cardiovascular care.