Using 14-day Continuous Electrocardiography Patch Monitoring to Detect Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke: a Protocol for a Prospective Single-arm Study Using a Historical Control for Comparison

Study design In this prospective, single-center, open-label, non-randomized, single- arm, historically controlled study, we will compare the detection rate of paroxysmal atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation, using 14-day continuous ECG patch monitoring, with a historical control group of patients who received serial 12-lead ECGs or 24-hour Holter monitoring. The study will be conducted in Chang Gung Memorial Hospital at Chiayi, Taiwan, from February 2022 to December 2024.

Study population Patients are eligible to participate if they meet the inclusion criteria and without the exclusion criteria. A historical control group will be drawn from our randomized clinical trial, which have been executed between October 2015 and October 2018, and aimed to evaluate the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation. Patients in the historical control group will have received serial 12-lead ECGs once daily for five days or conventional 24-hour Holter monitoring. In this study, serial ECGs had comparable detection rate of paroxysmal atrial fibrillation compared with 24-hour Holter monitoring. All clinical information and outcomes have been prospectively recorded.

Trial intervention Eligible patients in this study will receive 14-day continuous ECG patch monitoring.

A 14-day ECG patch monitor (EZYPRO, UG02, Sigknow Biomedical Co., Ltd, Taipei, Taiwan) was developed and evaluated in this study. The EZYPRO is a lightweight, waterproof, single-lead ECG device with no external leads or wires and allows for continuous ECG monitoring for up to 14 days. The data were collected and recorded by the investigators and analyzed with the proprietary analytical software and qualified ECG technicians from Sigknow Biomedical Co., Ltd. and adjudicated by attending cardiologists at the study site.

Study outcomes The primary outcome will be the percentage of patients with new atrial fibrillation. Atrial fibrillation was defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds.