NCT06542432
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
Enrolling by Invitation
NAAges 40–70InterventionalPreventionMyOme
~1,000 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Disclosure of integrate risk score for coronary artery disease
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing?
Measured over 5 years
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesMinnesota1
Pennsylvania1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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)
What this trial 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?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.