Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate disclosure of CAD PRS results, Deferred Disclosure of CAD PRS results.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PROACT 3: Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
Overview
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.
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.
Interventions
- Behavioral Immediate disclosure of CAD PRS results
Participants receive their CAD PRS results as soon as they are available after genotyping. - Behavioral Deferred Disclosure of CAD PRS results
Participants receive their CAD PRS results after completion of the 12 month follow up period.
Primary outcome measures
- Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months [Time frame: 12 months]
Secondary outcome measures (6)
- Change in Life's Essential 8 (LE8) score from baseline to 12 months [Time frame: 12 months]
- Completion of lipid panel and blood pressure measurement within 12 months [Time frame: 12 months]
- Attendance at primary care visit within 12 months [Time frame: 12 months]
- Initiation of preventive therapies within 12 months [Time frame: 12 months]
- Change in individual LE8 behavioral components from baseline to 12 months [Time frame: 12 months]
- Change in body mass index (BMI) from baseline to 12 months [Time frame: 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07087431 · 2025P001499 · R01HL164629