Disclosure of integrate risk score for coronary artery disease
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.
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
No
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 outcome measure(s)
Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing? — 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.
Does receiving an IRS report affect patient clinical measurements, including LDL-C levels? — 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.
Trial sites (2)
Facility
City
Region
Status
Mayo Clinic
Rochester
Minnesota
University of Pennsylvania
Philadelphia
Pennsylvania
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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