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Recruiting NCT07039123

Polygenic Risk Score for Optimizing Primary Prevention in Intermediate-Risk Populations

Trial Parameters

Condition Primary Prevention of Cardiovascular Disease
Sponsor University of Bern
Study Type INTERVENTIONAL
Phase N/A
Enrollment 204
Sex ALL
Min Age 40 Years
Max Age 69 Years
Start Date 2025-07-08
Completion 2026-09
Interventions
Polygenic Risk Score for Coronary Artery Disease (PRS-CAD)Standardized Risk Communication Tool (SCORE2)

Brief Summary

The goal of this clinical trial is to determine whether incorporating a polygenic risk score (PRS) can optimize primary cardiovascular disease prevention in individuals with intermediate cardiovascular risk. The main questions it aims to answer are: * Can a polygenic risk score improve risk stratification in intermediate-risk individuals? * Does disclosing polygenic risk information to patients and physicians lead to better preventive interventions (e.g., statin use, lifestyle changes)? Researchers will compare outcomes in participants with PRS disclosure versus standard risk assessment to see if PRS-guided prevention leads to improved cardiovascular risk management. Participants will: * Undergo baseline cardiovascular risk assessment * Provide a blood sample for PRS calculation * Complete follow-up visits for lifestyle counseling, medication review, and risk reassessment

Eligibility Criteria

Inclusion Criteria: * 40-69 years old * Intermediate cardiovascular risk based on SCORE2 or SCORE2-Diabetes * Able to give informed consent (understanding German or French or with an interpreter) * Written Informed Consent Exclusion Criteria: * Patient treated under lipid-lowering therapy (defined as statin, ezetimib, bempedoïc acid, PCSK-9 inhibitors) * History of previous cardiovascular disease: coronary artery disease (CAD), peripheral artery disease and ischemic stroke (including transitory ischemic stroke). * Chronic kidney disease (CKD) define as an estimated glomerular filtration rate (eGFR) of less than 30 ml/min or less than 60 ml/min with albuminuria patients with diabetes and end organ damage (classified as very high risk according to ESC guidelines). * Other participation in a clinical study related to CV risk or lifestyle interventions (e.g. diet, smoking cessation...) * Life expectancy of less than one year

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