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

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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Diagnostic test: Monthly 12-lead ECG

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ordu
    • Ordu, Ordu, Turkey (Türkiye), 52200
      • Ordu University Faculty of Medicine, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 e

Description

Inclusion Criteria:

• Age ≥65 years.
• Registered at a participating Family Health Center (ASM) in Ordu, Türkiye, with expected availability for 12 months of follow-up.
• Able to provide written informed consent

Exclusion Criteria:

• Prior diagnosis of atrial fibrillation or atrial flutter.
• Long-term therapeutic anticoagulation for any indication at baseline.
• Residence in long-term care, hospice, or palliative status.
• Enrollment in another interventional study that conflicts with the protocol.
• Planning to relocate or otherwise unable to attend monthly visits.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Group: Monthly 12-lead ECG screening + guideline-directed management; All enrolled participants receive monthly 12-lead ECG screening at ASMs for 12 months. Newly detected AF is managed by the tertiary Cardiology Department per routine care, including consideration of OAC when indicated.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident AF detection rate	Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up.	Baseline through Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to OAC initiation among incident AF	AF diagnosis to OAC start within 90 days
OAC adherence (MPR ≥80%)	Months 1-12 after OAC start
Ischemic events (ischemic stroke, TIA, systemic embolism)	Baseline to Month 12
Hemorrhagic events (ISTH major bleeding; clinically relevant non-major bleeding)	Baseline to Month 12
All-cause hospitalization	Baseline to Month 12
Net clinical outcome (ischemic stroke/TIA/systemic embolism, ISTH major bleeding, all-cause death)	Baseline to Month 12

Collaborators and Investigators

• Sponsor: Kotyora Family Medicine Health Management and Education Association
• Investigators: Study Chair: Seçkin Dereli, MD, Assoc. Prof., Ordu University Faculty of Medicine, Department of Cardiology (Turkey)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stroke; older adults; adherence; bleeding; primary care; oral anticoagulation; ECG screening
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage
• Other Study ID Numbers: KAHSED-003 (Other Identifier: Ordu University Non-Interventional Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No