Ordu University Faculty of Medicine, Department of Cardiology
Ordu, 52200, Turkey (Türkiye)
NCT Number: NCT07438054
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.
Interested in participating?
Request Info65 year and older
All sexes
Observational
Ordu, 52200, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline through Month 12
Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up.
Time frame: AF diagnosis to OAC start within 90 days
Time frame: Months 1-12 after OAC start
Time frame: Baseline to Month 12
Time frame: Baseline to Month 12
Time frame: Baseline to Month 12
Time frame: Baseline to Month 12
Kotyora Family Medicine Health Management and Education Association
Network
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07175428
Arrhythmias, Cardiac, Atrial Fibrillation
Dothan, Alabama, United States
View Trial DetailsNCT07441382
Anticoagulants, Arrhythmias, Cardiac
Guangzhou, Guangdong, China
View Trial DetailsNCT07626411
Arrhythmias, Cardiac, Atrial Fibrillation
View Trial DetailsNCT07450755
Arrhythmias, Cardiac, Atrial Fibrillation
View Trial Details