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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Incident AF detection rate [Срок оценки: Baseline through Month 12]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Ordu University Faculty of Medicine, Department of Cardiology — Ordu

Идентификаторы

NCT: NCT07438054 · KAHSED-003 · KAHSED-003 · KAHSED-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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