Giving adults their genetic risk score for coronary artery disease to see if it changes heart health.
PROACT 3: Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
This will see if telling adults aged 30–75 their genetic risk score for coronary artery disease changes LDL cholesterol and preventive care actions over one year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07087431 on ClinicalTrials.gov |
What this trial studies
The PROACT 3 trial randomizes 500 adults aged 30–75 who receive primary care within the Mass General Brigham network and are not taking LDL-lowering medications. All participants undergo a polygenic risk score test for coronary artery disease and are assigned 1:1 to immediate disclosure of results or deferred disclosure after about 12 months. The primary outcome is change in LDL cholesterol from baseline to 12 months, and secondary outcomes include change in the American Heart Association Life's Essential 8 score plus measures of engagement with preventive care (lipid panels, blood pressure checks, primary care visits, and initiation of preventive therapies). The single-center trial uses electronic health record queries to identify eligible patients and is conducted at Massachusetts General Hospital.
Who should consider this trial
Good fit: Adults 30–75 with established primary care at Mass General Brigham who do not have cardiovascular disease and are not currently taking LDL-lowering medications.
Not a fit: People already on statins or other LDL-lowering drugs, those with existing cardiovascular disease, or those without Mass General Brigham primary care would not qualify and are unlikely to benefit from this study's approach.
Why it matters
Potential benefit: If successful, disclosing genetic risk could prompt earlier lifestyle or medication changes that lower LDL cholesterol and reduce long-term heart disease risk.
How similar studies have performed: Prior studies of disclosing polygenic risk scores for coronary disease have been limited and shown mixed results, with some modest increases in preventive actions but inconsistent effects on cholesterol levels.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Roukoz Karam, MD
- Email: proact@mgb.org
- Phone: 6174121147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.