Prediction of Atrial Fibrillation Using Polygenic Risk Score
ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-79
SponsorSeoul St. Mary's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
7-day continuous ECG patch monitor
DeviceContinuous ECG patch worn for 7 days at enrollment to detect atrial fibrillation and other arrhythmias.
Six-lead handheld electrocardiogram device
DeviceSix-lead ECG device used for self-monitoring at least once or twice weekly and upon symptoms for 1 year.
SNP array genotyping
GeneticDNA 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.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: AF Risk GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of newly diagnosed atrial fibrillation
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.
Time frame
1 yearSecondary outcomes
1
Incidence of newly diagnosed atrial flutter
New diagnosis of atrial flutter confirmed by ECG monitoring during the 1-year follow-up period.
Time frame
1 year2
Predictive performance of the AF prediction model
Discrimination and calibration of a scoring system integrating polygenic risk score and clinical risk factors for predicting atrial fibrillation, assessed by area under the receiver operating characteristic curve (AUC).
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov