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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07087431
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Mar 2026
Primary completion
Oct 15, 2026
Completion
Aug 15, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Akl Fahed, MD, MPH
[email protected]
6176434842

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By research site
Massachusetts General Hospital· Boston, MA

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