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OpenTrials
Enrolling by Invitation

NCT Number: NCT07438054

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

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.

Enrolling by Invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordu University Faculty of Medicine, Department of Cardiology

Ordu, 52200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Incident AF detection rate

    Time frame: Baseline through Month 12

    Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up.

Secondary outcomes

  1. Time to OAC initiation among incident AF

    Time frame: AF diagnosis to OAC start within 90 days

  2. OAC adherence (MPR ≥80%)

    Time frame: Months 1-12 after OAC start

  3. Ischemic events (ischemic stroke, TIA, systemic embolism)

    Time frame: Baseline to Month 12

  4. Hemorrhagic events (ISTH major bleeding; clinically relevant non-major bleeding)

    Time frame: Baseline to Month 12

  5. All-cause hospitalization

    Time frame: Baseline to Month 12

  6. Net clinical outcome (ischemic stroke/TIA/systemic embolism, ISTH major bleeding, all-cause death)

    Time frame: Baseline to Month 12

Sponsors and collaborators

Lead sponsor

Kotyora Family Medicine Health Management and Education Association

Network

Registry information

Official study 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)

Acronym: PRO-AF 52

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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