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Active, not recruiting Not applicable

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

NCT07039123 · tracked via the Priya Life Science Switzerland tracker
Phase
Not applicable
Started
2025-07-08
Last updated
2026-06-30

Condition(s) studied

Primary Prevention of Cardiovascular Disease

Investigational drug(s) / intervention(s)

Polygenic Risk Score for Coronary Artery Disease (PRS-CAD)Standardized Risk Communication Tool (SCORE2)

Polygenic Risk Score for Coronary Artery Disease (PRS-CAD): 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.

Standardized Risk Communication Tool (SCORE2): 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.

Study 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

Sex
ALL
Min age
40 Years
Max age
69 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in SCORE2 between baseline and 18 months — 18 months
    Mean change in SCORE2 cardiovascular risk score from baseline to 18-month follow-up, comparing the intervention (PRS-CAD + SCORE2) and control (SCORE2 only) arms.

Trial sites (2)

FacilityCityRegionStatus
University of Bern, Institute of Primary Health Care (BIHAM) Bern Switzerland
Hôpital Fribourgeois (HFR) Fribourg Switzerland
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.

View NCT07039123 on ClinicalTrials.gov ↗ ← All trials in Switzerland