Polygenic Risk Score for Optimizing Primary Prevention in Intermediate-Risk Populations
Polygenic Risk Score to Optimize Primary Prevention in Intermediate Risk Population (PERSONAL)
University of Bern
204 participants
Jul 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- -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 Criteria5
- 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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Interventions
A polygenic risk score will be calculated based on genome-wide genotyping and combined with SCORE2 clinical risk factors to estimate personalized cardiovascular risk. The combined risk (PRS-CAD-SCORE2) will be communicated to participants and their healthcare providers using a standardized communication tool. Participants with elevated risk will be referred to a lipid clinic.
Participants will receive risk communication based solely on clinical risk factors using the SCORE2 algorithm. The same structured communication tool will be used (without genetic data), along with general lifestyle guidance.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07039123