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ENROLLING BY INVITATION
NCT07438054

PRO-AF 52: Monthly Primary-Care 12-Lead ECG Screening for Incident Atrial Fibrillation in Adults Aged ≥65 Years

Sponsor: Kotyora Family Medicine Health Management and Education Association

View on ClinicalTrials.gov

Summary

This prospective, single-arm study will evaluate the feasibility and yield of monthly, in-clinic 12-lead electrocardiogram (ECG) screening performed at affiliated Family Health Centers (Aile Sağlığı Merkezleri; ASMs) in Ordu, Türkiye, among community-dwelling adults aged ≥65 years without a prior diagnosis of atrial fibrillation (AF). Each participant will be followed for 12 months (12 visits). New AF will be confirmed on ASM-acquired 12-lead ECG and managed by the tertiary Cardiology Department according to contemporary guidelines, including initiation of oral anticoagulation (OAC) when indicated. Outcomes include incident AF detection, OAC initiation and adherence, and ischemic/hemorrhagic clinical events.

Official title: A Prospective, Single-Group, Primary-Care-Based 12-Lead ECG Screening Program With 12-Month Follow-up for Incident Atrial Fibrillation and Guideline-Directed Oral Anticoagulation in Ordu, Türkiye (PRO-AF 52)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Monthly 12-lead ECG

Standard resting 12-lead ECG performed at each monthly visit (12 visits over 12 months), centrally interpreted by cardiologists. No wearable/PPG devices or ambulatory patches are used in the protocol

Locations (1)

Ordu University Faculty of Medicine, Department of Cardiology

Ordu, Ordu, Turkey (Türkiye)