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RECRUITING
NCT07641582
NA

Prediction of Atrial Fibrillation Using Polygenic Risk Score

Sponsor: Seoul St. Mary's Hospital

View on ClinicalTrials.gov

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.

Official title: Development of an Atrial Fibrillation Prediction Model Using Polygenic Risk Score: A Prospective Cohort Study

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2024-11-19

Completion Date

2027-06-30

Last Updated

2026-06-11

Healthy Volunteers

No

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.

Locations (5)

The Catholic University of Korea Incheon St. Mary's Hospital

Incheon, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea