Coronary Artery DiseasePROACT 3NCT07087431
Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
A study testing Immediate disclosure of CAD PRS results and Deferred Disclosure of CAD PRS results in people with Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Immediate disclosure of CAD PRS results and Deferred Disclosure of CAD PRS results
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current age 30-75 years
- Established primary care at Mass General Brigham with at least one visit in the last 2 years
Who cannot join
- Currently taking LDL cholesterol- lowering medications, including statins
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Akl Fahed, MD, MPH, 6176434842, afahed@mgh.harvard.edu
About this study
Official title: PROACT 3: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Immediate disclosure of CAD PRS results, Deferred Disclosure of CAD PRS results
- Keywords
- Polygenic risk, Atherosclerosis, Genetics, Genomic medicine, Polygenic score, Precision medicine, Preventive cardiology, Polygenic risk score, CAD PRS
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate disclosure of CAD PRS resultsBehavioural
Participants receive their CAD PRS results as soon as they are available after genotyping.
Deferred Disclosure of CAD PRS resultsBehavioural
Participants receive their CAD PRS results after completion of the 12 month follow up period.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Disclosure | Experimental | Participants are randomized to receive their CAD PRS results after genotyping. Receives: Behavioral: Immediate disclosure of CAD PRS results |
| Deferred Disclosure | Active comparator | Participants are randomized to have their CAD PRS results withheld until approximately 12 months after enrollment. Receives: Behavioral: Deferred Disclosure of CAD PRS results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 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.
Measured: 12 months
Secondary outcomes (6)
Change in Life's Essential 8 (LE8) score from baseline to 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.
Measured: 12 months
Completion of lipid panel and blood pressure measurement within 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.
Measured: 12 months
Attendance at primary care visit within 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.
Measured: 12 months
Initiation of preventive therapies within 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.
Measured: 12 months
Change in individual LE8 behavioral components from baseline to 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.
Measured: 12 months
Change in body mass index (BMI) from baseline to 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Akl C. Fahed, MD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087431
- Sponsor's protocol ID
- 2025P001499
- Other IDs
- R01HL164629
- Acronym
- PROACT 3
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be tabulated and analyzed. Study site will not share any of the subject identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROACT 3: Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07087431
- Acronym / sponsor ID
- PROACT 3 / 2025P001499
- Conditions
- Coronary Artery Disease
- Keywords
- Polygenic risk, Atherosclerosis, Genetics, Genomic medicine, Polygenic score, Precision medicine, Preventive cardiology, Polygenic risk score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Disclosure | Experimental | Behavioral: Immediate disclosure of CAD PRS resultsParticipants are randomized to receive their CAD PRS results after genotyping. |
| Deferred Disclosure | Active comparator | Behavioral: Deferred Disclosure of CAD PRS resultsParticipants are randomized to have their CAD PRS results withheld until approximately 12 months after enrollment. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current age 30-75 years
- Established primary care at Mass General Brigham with at least one visit in the last 2 years
Key exclusion criteria (1 listed)
- Currently taking LDL cholesterol- lowering medications, including statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate disclosure of CAD PRS resultsParticipants receive their CAD PRS results as soon as they are available after genotyping. | Behavioural | Immediate Disclosure |
| Deferred Disclosure of CAD PRS resultsParticipants receive their CAD PRS results after completion of the 12 month follow up period. | Behavioural | Deferred Disclosure |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be tabulated and analyzed. Study site will not share any of the subject identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate disclosure of CAD PRS results and Deferred Disclosure of CAD PRS results in people with Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roukoz Karam, MD (6174121147, proact@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.