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Prediction of Atrial Fibrillation Using Polygenic Risk Score

NCT07641582 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-06-11

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether a genetic risk score can help identify undiagnosed atrial fibrillation (AF) in adults who may have it. AF is an irregular heartbeat that raises the risk of stroke if not treated early.

The main questions it aims to answer are:

Can a polygenic risk score (PRS) - a score based on a person's genes - identify who is more likely to have AF? Does combining PRS with a person's medical history predict AF better than using medical history alone?

Participants will:

Wear a continuous ECG patch for 7 days to record heart rhythm Give a blood sample for genetic testing to calculate their PRS Use a six-lead handheld ECG device (HATIV® P30, VUNO Inc., Seoul, Republic of Korea) to check their own heart rhythm at home once or twice a week for 1 year Visit the clinic 5 times over 1 year

Researchers will use the genetic and clinical information collected to build a scoring system that predicts who is at risk for AF.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

7-day continuous ECG patch monitor

Continuous ECG patch worn for 7 days at enrollment to detect atrial fibrillation and other arrhythmias.

DEVICE

Six-lead handheld electrocardiogram device

Six-lead ECG device used for self-monitoring at least once or twice weekly and upon symptoms for 1 year.

GENETIC

SNP array genotyping

DNA extracted from a 5cc blood sample is used to perform SNP array genotyping. The resulting data are used to calculate a polygenic risk score (PRS) for atrial fibrillation based on previously published genome-wide association study results.

Sponsors & Collaborators

  • Seoul St. Mary's Hospital

    lead OTHER

Principal Investigators

  • Young Choi, MD, PhD · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-12-30
Completion
2027-06-30

Countries

  • South Korea

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 NCT07641582 on ClinicalTrials.gov