Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
MyOme
Study ID
NCT06542432
Status
Enrolling By Invitation

Conditions

  • Cardiovascular Diseases
  • Coronary Artery Disease
  • Coronary Disease
  • Heart Diseases
  • Myocardial Infarction
  • Polygenic Risk Score

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Disclosure of integrate risk score for coronary artery disease — GENETIC
    Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results.

Study Details

The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.

Key Dates

Start date
Jan 1, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental: Intervention
    Participants will receive their integrated risk score result for coronary artery disease.
  • No Intervention: No Intervention: Control
    Participants will only receive standard of care ASCVD Pooled Cohorts Equation (ASCVD PCE), and disclosure of integrated risk score result will be deferred until 3 years after enrollment.

Primary Outcome Measure

Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing? [ Time Frame: 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNUniversity of Pennsylvania· Philadelphia, PA

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