Coronary Artery Disease
Conditions
Keywords
Polygenic risk, Atherosclerosis, Genetics, Genomic medicine, Polygenic score, Precision medicine, Preventive cardiology, Polygenic risk score, CAD PRS
Brief 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 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
BEHAVIORALImmediate disclosure of CAD PRS results
Participants receive their CAD PRS results as soon as they are available after genotyping.
BEHAVIORALDeferred Disclosure of CAD PRS results
Participants receive their CAD PRS results after completion of the 12 month follow up period.
Sponsors
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Life's Essential 8 (LE8) score from baseline to 12 months | 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. |
| Completion of lipid panel and blood pressure measurement within 12 months | 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. |
| Attendance at primary care visit within 12 months | 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. |
| Initiation of preventive therapies within 12 months | 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. |
| Change in individual LE8 behavioral components from baseline to 12 months | 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. |
| Change in body mass index (BMI) from baseline to 12 months | 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. |
Countries
United States
Contacts
CONTACTRoukoz Karam, MD
Outcome results
None listed