Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Disclosure of integrate risk score for coronary artery disease.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Polygenic Risk Score, Heart Diseases, Coronary Disease. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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]
- Does receiving an IRS report affect patient clinical measurements, including LDL-C levels? [Time frame: 5 years]
Secondary outcome measures (3)
- Does the IRS identify those at elevated risk for CAD and future ASCVD events? [Time frame: 5 years]
- Does receiving an IRS report affect the incidence of CAD events? [Time frame: 5 years]
- Does receiving an IRS report affect participant understanding of their individual CAD risk? [Time frame: 5 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Mayo Clinic — Rochester
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06542432 · 004