Optimal Detection of Atrial Fibrillation in Transient Ischaemic Attack: Rationale and design of the ODEA-TIA trial

The detection of atrial fibrillation (AF) after transient ischemic attacks (TIA) is crucial for initiating effective secondary prevention using oral anticoagulation. The choice of the best method and the duration of ECG monitoring to detect AF is uncertain. ODEA-TIA is a multicenter, investigator-initiated, randomized, open-label, blinded-endpoint clinical trial designed to compare three ECG monitoring strategies for detecting AF in patients aged 50 years or older who experienced a TIA within 28 days before randomization and had no prior history of AF. Participants are randomly assigned in a 1:1:1 ratio, stratified by age and center, to undergo either 24-hour Holter ECG, 28-day noninvasive continuous ECG patch monitoring, or continuous recording with a subcutaneously implantable loop recorder for up to 2-years. The primary endpoint is the rate of newly detected AF within 6 months after study enrolment. Secondary endpoints include AF detection at 12 and 24 months, and overall prevalence of AF during follow-up in long-term recordings. Exploratory analyses include clinical outcomes, initiation of anticoagulation, and performance parameters. A substudy investigates the usefulness of blood-based biomarkers to predict AF. ODEA-TIA aims to establish evidence-based ECG monitoring strategies for the detection of AF to improve secondary prevention in TIA patients.