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NCT Number: NCT07087431

Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Genetic Risk Score Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Akl Fahed, MD, MPH

CONTACT

[email protected]

6176434842

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate disclosure of CAD PRS results

Behavioral

Participants receive their CAD PRS results as soon as they are available after genotyping.

Deferred Disclosure of CAD PRS results

Behavioral

Participants receive their CAD PRS results after completion of the 12 month follow up period.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Life's Essential 8 (LE8) score from baseline to 12 months

    Time frame: 12 months

    Change in cardiovascular health as measured by the American Heart Association's LE8 score from baseline to 12 months. The LE8 score integrates four health behaviors (diet, physical activity, nicotine exposure, and sleep) and four health factors (body mass index, blood lipids, blood glucose, and blood pressure) into a single metric ranging from 0 (poor health) to 100 (ideal health). Changes will be compared between the two randomized groups.

  2. Completion of lipid panel and blood pressure measurement within 12 months

    Time frame: 12 months

    Proportion of participants who complete a lipid panel and have blood pressure measured within 12 months of randomization, based on electronic health record data will be compared between the two groups to assess engagement with preventive care.

  3. Attendance at primary care visit within 12 months

    Time frame: 12 months

    Proportion of participants attending at least one primary care visit within 12 months of randomization, as documented in the electronic health record, will be compared between the two groups to assess engagement with routine medical care.

  4. Initiation of preventive therapies within 12 months

    Time frame: 12 months

    Proportion of participants initiating antihypertensive, lipid-lowering, GLP-1 receptor agonist, or other anti-diabetic therapy within 12 months when clinically indicated, based on prescription records, will be compared between the two groups to assess proactive management of cardiovascular risk factors.

  5. Change in individual LE8 behavioral components from baseline to 12 months

    Time frame: 12 months

    Change in physical activity, diet, tobacco use, and sleep health from baseline to 12 months, as assessed by self-reported survey responses and calculated as individual components of the LE8 score, will be compared between the two groups to assess differences in health behaviors.

  6. Change in body mass index (BMI) from baseline to 12 months

    Time frame: 12 months

    Change in BMI, calculated from height and weight measurements obtained from electronic health records, will be compared between the two groups to assess differences in weight management.

Study contacts

Contact information is provided by the study sponsor or research team.

Roukoz Karam, MD

CONTACT

[email protected]

6174121147

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

PROACT 3: Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health

Acronym: PROACT 3

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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