Atrial Fibrillation (AF)
Conditions
Keywords
ECG screening, primary care, older adults, oral anticoagulation, adherence, stroke, bleeding
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.
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.
Interventions
DIAGNOSTIC_TESTMonthly 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
Sponsors
Kotyora Family Medicine Health Management and Education Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident AF detection rate | Baseline through Month 12 | Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up. |
Secondary
| 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 |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSeçkin Dereli, MD, Assoc. Prof.
Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
Outcome results
None listed