NCT07438054

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

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)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Kotyora Family Medicine Health Management and Education Association · Network
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants aged ≥65 years registered at participating ASMs will undergo monthly standard resting 12-lead ECGs captured on site by trained primary-care staff. All ECGs will be centrally reviewed and reported by cardiologists from the tertiary Cardiology Department. ECG is the only screening/diagnostic tool in the protocol; no wearable/photoplethysmography (PPG) devices or ambulatory patches are used. Participants with newly detected AF will be referred to the tertiary Cardiology Department for guideline-directed care. Decisions regarding OAC initiation, dosing, drug choice, bleeding risk mitigation, and follow-up are made by cardiology as part of routine clinical practice. Participants with sinus rhythm on ASM ECG but palpitations or related symptoms will also be evaluated by cardiology; any additional tests (e.g., Holter monitoring) are outside the study interventions and performed as usual care. At each monthly visit, study staff will capture symptoms, vitals, medications, adverse events, and an ECG. Endpoint events will be source-verified (hospital records, imaging, discharge summaries) and adjudicated by a blinded outcomes committee. Visit windows are ±7 days.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-30
• Completion: 2027-12-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)