Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05819814
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

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

Interventions

  • Disclosure of high polygenic risk result for coronary artery disease — BEHAVIORAL
    The disclosure of a high polygenic risk result for coronary artery disease involves a clinical report coupled with a virtual meeting with a genetic counselor.

Study Details

The goal of this randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health over one year.

Key Dates

Start date
Dec 7, 2023
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
May 1, 2027

Study Design

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

Arms

  • Experimental: Intervention
    Participants will receive their high polygenic risk result for coronary artery disease.
  • No Intervention: Control
    Participants will receive standard of care, and disclosure of high polygenic risk result will be deferred until study completion.

Primary Outcome Measure

Assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Akl C Fahed, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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