Prediction of Atrial Fibrillation Using Polygenic Risk Score

NCT07641582 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul St. Mary's Hospital

Phase

Not applicable

Started

2024-11-19

Last updated

2026-06-11

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

7-day continuous ECG patch monitorSix-lead handheld electrocardiogram deviceSNP array genotyping

7-day continuous ECG patch monitor: Continuous ECG patch worn for 7 days at enrollment to detect atrial fibrillation and other arrhythmias.

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.

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.

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.

Eligibility

Sex

ALL

Min age

20 Years

Max age

79 Years

Healthy volunteers

Inclusion Criteria: * Patients with symptoms suggestive of paroxysmal atrial fibrillation, such as intermittent palpitations or chest discomfort * Asymptomatic patients aged 60 or older with at least one of the following risk factors for atrial fibrillation: hypertension, diabetes, coronary artery disease, valvular heart disease, cardiomyopathy, sleep apnea, hyperthyroidism, obesity (BMI greater than 30), or chronic alcohol dependence (drinking more than 3 times per week) Exclusion Criteria: * Age under 20 years or over 80 years * Moderate or severe cognitive impairment * Previously diagnosed with atrial fibrillation prior to study enrollment * Does not consent to participate in the study

Primary outcome measure(s)

Incidence of newly diagnosed atrial fibrillation — 1 year
New diagnosis of atrial fibrillation confirmed by 7-day continuous ECG patch monitor, six-lead handheld ECG device, or standard 12-lead ECG during the 1-year follow-up period.

Trial sites (5)

Facility	City	Region	Status
The Catholic University of Korea Incheon St. Mary's Hospital	Incheon	South Korea	Recruiting
The Catholic University of Korea Seoul St. Mary's Hospital	Seoul	South Korea	Recruiting
The Catholic University of Korea Eunpyeong St. Mary's Hospital	Seoul	South Korea	Recruiting
The Catholic University of Korea St. Vincent's Hospital	Suwon	South Korea	Recruiting
The Catholic University of Korea Uijeongbu St. Mary's Hospital	Uijeongbu-si	South Korea	Recruiting

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Official registry record

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 NCT07641582 on ClinicalTrials.gov ↗ ← All trials in South Korea