Polygenic Risk Score for Optimizing Primary Prevention in Intermediate-Risk Populations
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Bern, Institute of Primary Health Care (BIHAM) | Bern | Switzerland | |
| Hôpital Fribourgeois (HFR) | Fribourg | Switzerland |
More University of Bern trials in Switzerland
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