Serial Electrocardiogram Versus Holter to Detect Atrial Fibrillation in Acute Ischemic Stroke---A Randomized Controlled Trial

Background: Among ischemic stroke patients, atrial fibrillation is associated with a high annual risk of stroke recurrence, and strategies to improve the detection and treatment of atrial fibrillation promise to reduce the burden of recurrent strokes. Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the UK guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history. Methods: We plan to enroll 600 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted due to acute ischemic stroke within 7 days, with 20 years of age or older, do not have known atrial fibrillation on history or baseline ECG at admission. We will randomly assigned participants in a 1:1 ratio to undergo 12-lead ECG once daily for 5 days (intervention group) or 24-hour Holter monitoring (control group). Primary outcome is newly detected atrial fibrillation on 12-lead ECG vs. atrial fibrillation on Holter after randomization. Secondary outcomes included duration from admission to newly atrial fibrillation identified in each group and anticoagulation status in patients with newly diagnosed atrial fibrillation at discharge. Prospective: If serial ECG is an effective way to identify new cases of atrial fibrillation, it can be widely used in all levels, from medical center to area hospital, for acute ischemic stroke patients.

Project ID:PC10408-2179
External Project ID:MOST104-2314-B182-019