Clinical trial NCT06542432: Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
Official title: A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Artery Disease
Polygenic Risk Score
Heart Diseases
Coronary Disease
Myocardial Infarction
Cardiovascular Diseases
Keywords: Polygenic risk score
Integrated risk score
Genetics
Cardiovascular health
Coronary artery disease
Precision medicine
Lead sponsor: MyOme
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2024-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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)

Primary outcomes:
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?
timeFrame: 5 years
measure: Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?
timeFrame: 5 years
Secondary outcomes:
measure: Does the IRS identify those at elevated risk for CAD and future ASCVD events?
timeFrame: 5 years
measure: Does receiving an IRS report affect the incidence of CAD events?
timeFrame: 5 years
measure: Does receiving an IRS report affect participant understanding of their individual CAD risk?
timeFrame: 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: