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

NCT07438054 | Enrolling By Invitation

• 1 other identifier: KAHSED-003
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Keywords

ECG screening; primary care; older adults; oral anticoagulation; adherence; stroke; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

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

Interventions

Monthly 12-lead ECG DIAGNOSTIC_TEST

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

Single Group: Monthly 12-lead ECG screening + guideline-directed management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kotyora Family Medicine Health Management and Education Association: lead

Study Sites (1)

Ordu University Faculty of Medicine, Department of Cardiology

Ordu, Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Seçkin Dereli, MD, Assoc. Prof.

  Ordu University Faculty of Medicine, Department of Cardiology (Turkey)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)