Polygenic Risk Score to Optimize Primary Prevention in Intermediate Risk Population (PERSONAL)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 69
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University of Bern, Institute of Primary Health Care (BIHAM)
RECRUITING
Bern
University of Lausanne, Centre Hospitalier Universitaire Vaudois (CHUV)
NOT_YET_RECRUITING
Lausanne
Contact Information
Primary
Elisavet Moutzouri, MD, PhD
elisavet.moutzouri@extern.insel.ch
+41792725451
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2027-10
Participants
Target number of participants: 204
Treatments
Experimental: Polygenic Risk Score Combined with SCORE2
Participants in this arm will receive cardiovascular risk assessment using a combination of traditional clinical risk factors (SCORE2 algorithm) and a polygenic risk score for coronary artery disease (PRS-CAD). The combined risk (PRS-CAD-SCORE2) will be communicated using a structured communication tool developed by the study team. Participants and their healthcare providers will receive the results, and those with elevated risk will be referred to a lipid consultation. Lifestyle guidance and educational materials will also be provided.
Active_comparator: SCORE2-Based Risk Assessment
Participants in this arm will receive standard cardiovascular risk assessment using the SCORE2 algorithm only. Risk results will be communicated using the same structured communication tool, without inclusion of genetic information. No polygenic risk score will be calculated or disclosed. Participants and their healthcare providers will receive the standard risk results and general lifestyle recommendations.
Related Therapeutic Areas
Sponsors
Leads: University of Bern

This content was sourced from clinicaltrials.gov