NCT07087431 · Massachusetts General Hospital
Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
(PROACT 3)
What this study is about
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.
View original scientific description
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.
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
The primary outcome is the change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months. LDL-C values will be obtained from clinical measurements recorded in the electronic health record. The analysis will compare the change in LDL-C between participants randomized to immediate disclosure versus deferred disclosure of CAD PRS results.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations