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

NCT07039123 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-07-25

No results posted yet for this 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

Conditions

  • Primary Prevention of Cardiovascular Disease

Interventions

DIAGNOSTIC_TEST

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Nicolas Rodondi, MD · University hospital of Bern

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2026-09-30
Completion
2027-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039123 on ClinicalTrials.gov