RecruitingNot ApplicableNCT07641582

Prediction of Atrial Fibrillation Using Polygenic Risk Score

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


Sponsor

Seoul St. Mary's Hospital

Enrollment

800 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 79 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

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Interventions

DEVICE7-day continuous ECG patch monitor

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

DEVICESix-lead handheld electrocardiogram device

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

GENETICSNP 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

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NCT07641582


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