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Prediction of Atrial Fibrillation Using Polygenic Risk Score (PREGENCE)

6. juni 2026 opdateret af: Young Choi, Seoul St. Mary's Hospital

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, affecting approximately 34 million individuals. While early diagnosis and treatment can significantly reduce the risk of stroke, paroxysmal AF often goes undetected due to its intermittent nature. Current screening guidelines lack clear recommendations on which populations benefit most from AF screening and what screening strategies are optimal.

Genome-wide association studies have identified numerous genetic loci associated with AF susceptibility, and the SNP heritability of AF has been estimated at approximately 22%. A polygenic risk score (PRS) aggregates the effects of thousands of common genetic variants across the genome to estimate an individual's genetic predisposition to AF. Prior studies have demonstrated that PRS can stratify AF risk independently of conventional clinical risk factors, suggesting its potential utility in targeted screening strategies.

Genetic Assessment At enrollment, a blood sample of 5cc is collected for DNA extraction via centrifugation. A SNP array is performed using a commercially available SNP chip kit. The resulting genotype data are used to calculate a weighted PRS for AF based on previously published genome-wide association study results.

ECG Monitoring In addition to standard 12-lead ECG and 7-day continuous ECG patch monitoring performed at enrollment, all participants are provided with a six-lead handheld ECG device (HATIV® P30, VUNO Inc., Seoul, Republic of Korea). Participants perform self-ECG recordings at least once or twice per week and additionally upon symptom onset for 1 year after enrollment.

Prediction Model Development At the end of follow-up, participants are classified into AF-diagnosed and non-AF groups. A scoring system integrating clinical history and PRS will be developed to predict AF occurrence and its predictive performance will be evaluated.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

800

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Sydkorea
      • Incheon, Sydkorea
        • Rekruttering
        • The Catholic University of Korea Incheon St. Mary's Hospital
      • Seoul, Sydkorea
        • Rekruttering
        • The Catholic University of Korea Eunpyeong St. Mary's Hospital
      • Seoul, Sydkorea, 06591
        • Rekruttering
        • The Catholic University of Korea Seoul St. Mary's Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Young Choi, MD, PhD
      • Suwon, Sydkorea
        • Rekruttering
        • The Catholic University of Korea St. Vincent's Hospital
      • Uijeongbu-si, Sydkorea
        • Rekruttering
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AF Risk Group
Participants at risk for atrial fibrillation undergo 7-day continuous ECG patch monitoring and SNP array genotyping at enrollment, followed by 1-year self-monitoring with a six-lead handheld ECG device (HATIV® P30, VUNO Inc.).
Enhed: 7-day continuous ECG patch monitor
Continuous ECG patch worn for 7 days at enrollment to detect atrial fibrillation and other arrhythmias.
Enhed: 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.
Andre navne:
  • HATIV® P30
Genetisk: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of newly diagnosed atrial fibrillation
Tidsramme: 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.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of newly diagnosed atrial flutter
Tidsramme: 1 year
New diagnosis of atrial flutter confirmed by ECG monitoring during the 1-year follow-up period.
1 year
Predictive performance of the AF prediction model
Tidsramme: 1 year
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).
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul St. Mary's Hospital

Efterforskere

  • Ledende efterforsker: Young Choi, MD, PhD, The Catholic University of Korea

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. november 2024

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

6. juni 2026

Først indsendt, der opfyldte QC-kriterier

6. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KC24ENSI0366
  • RS-2024-00357346 (Andet bevillings-/finansieringsnummer: National Research Foundation of Korea)

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Kliniske forsøg med Atrieflimren (AF)

Kliniske forsøg med 7-day continuous ECG patch monitor

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