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

September 10, 2025 updated by: MyOme

A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
  • No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
  • Previously genotyped as part of a research study that enables recontact of participants
  • Receiving primary care at a participating institution.

Exclusion Criteria:

  • Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
  • Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
  • Future use of statins contraindicated
  • Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
  • Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
  • Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Intervention
Participants will receive their integrated risk score result for coronary artery disease.
Genetic: Disclosure of integrate risk score for coronary artery disease
Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group.
5 years
Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?
Time Frame: 5 years
Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does the IRS identify those at elevated risk for CAD and future ASCVD events?
Time Frame: 5 years
Aggregated longitudinal clinical data and patient survey data will be collected to compare patient clinical outcomes in those with a high CAD IRS.
5 years
Does receiving an IRS report affect the incidence of CAD events?
Time Frame: 5 years
Aggregated longitudinal clinical data will be collected to compare patient clinical outcomes in those with a CAD IRS reported at baseline and the control group.
5 years
Does receiving an IRS report affect participant understanding of their individual CAD risk?
Time Frame: 5 years
Patient survey data will be collected to assess their understanding of their CAD risk.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MyOme

Collaborators

Mayo Clinic
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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