Recruiting

Coronary Artery Disease

Sponsor:

Massachusetts General Hospital

Code:

NCT07087431

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Immediate disclosure of CAD PRS results

Deferred Disclosure of CAD PRS results

Study Details

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.

Conditions

Coronary Artery Disease

Study ID

NCT07087431

Start date

Oct 15, 2025

Status verified date

Mar, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Oct 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Immediate Disclosure

Participants are randomized to receive their CAD PRS results after genotyping.

active comparator: Deferred Disclosure

Participants are randomized to have their CAD PRS results withheld until approximately 12 months after enrollment.

Interventions

Immediate disclosure of CAD PRS results

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

Deferred Disclosure of CAD PRS results

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

Primary outcome measure

  • Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Roukoz Karam, MD

6174121147proact@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Akl Fahed, MD, MPH

6176434842afahed@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Polygenic risk
  • Atherosclerosis
  • Genetics
  • Genomic medicine
  • Polygenic score
  • Precision medicine
  • Preventive cardiology
  • Polygenic risk score
  • CAD PRS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-23.