Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong.
Neurology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong.
BMJ Open. 2022 Jul 15;12(7):e053466. doi: 10.1136/bmjopen-2021-053466.
Current international guidelines recommend ECG monitoring after an ischaemic stroke to detect atrial fibrillation (AF) in order to prevent stroke recurrence. However, optimal strategies to detect AF and the downstream management to prevent stroke recurrence remain to be established. The objective of the study was to explore the use of long-term home-based ECG monitoring for AF detection and stroke prevention in patients with a history of stroke.
This prospective, randomised, open-label trial with blinded endpoint adjudication aimed to evaluate the efficacy of long-term home-based ECG monitoring for AF detection and stroke prevention in a 24-month period. Patients aged >18 years with a history of ischaemic stroke will be stratified according to the time from the index ischaemic stroke: <1, 1-3 and >3 years and then randomised in 1:1 to (1) home-based AF screening and (2) control. The home-based AF screening system comprises (1) a handheld single-lead ECG recorder (Comfit Healthcare Devices, Hong Kong SAR, China) and (2) a patient-facing smartphone application specially designed for the study. Patients randomised to the home-based AF group will record a 30 s single-lead ECG using a specially designed handheld ECG device every morning or when symptomatic. All remotely obtained data will be automatically transmitted in real-time through the study smartphone application to a secured cloud hosting and analysed using an artificial intelligence-based diagnostic system. When a diagnosis of AF is made with the system, the patients will be called back for a formal cardiology consultation within 1 week. The primary endpoint is the time to first detection of AF at 24 months of follow-up. Secondary endpoints include recurrent stroke or transient ischaemic attack, initiation of long-term anticoagulation therapy, hospitalisation for heart failure, cardiovascular death and all-cause death.
The study protocol has been approved by the institutional review board of The University of Hong Kong, and Hong Kong West Cluster, Hospital Authority, Hong Kong SAR, China. Results will be published in peer-reviewed journals.
NCT04523649.
目前的国际指南建议对缺血性卒中后进行心电图监测，以检测心房颤动（AF），从而预防卒中复发。然而，检测 AF 的最佳策略以及预防卒中复发的下游管理仍有待建立。本研究旨在探讨长期家庭心电图监测在有卒中史患者中检测 AF 和预防卒中的作用。
这是一项前瞻性、随机、开放标签、终点盲法评估试验，旨在评估 24 个月期间长期家庭心电图监测在 AF 检测和卒中预防中的疗效。年龄>18 岁、有缺血性卒中史的患者将根据从指数缺血性卒中的时间进行分层：<1 年、1-3 年和>3 年，然后按 1:1 随机分为（1）家庭 AF 筛查组和（2）对照组。家庭 AF 筛查系统包括（1）手持式单导联心电图记录仪（中国香港特别行政区 Comfit Healthcare Devices）和（2）专为该研究设计的面向患者的智能手机应用程序。随机分配至家庭 AF 组的患者将每天早晨或出现症状时使用专门设计的手持式心电图设备记录 30 秒单导联心电图。所有远程获取的数据将通过研究智能手机应用程序实时自动传输，并使用基于人工智能的诊断系统进行分析。当系统做出 AF 诊断时，将在 1 周内回拨患者进行正式的心脏病学咨询。主要终点是 24 个月随访时首次检测到 AF 的时间。次要终点包括复发性卒中或短暂性脑缺血发作、开始长期抗凝治疗、因心力衰竭住院、心血管死亡和全因死亡。
该研究方案已获得香港大学、中国香港特别行政区医管局香港西联网机构审查委员会的批准。结果将发表在同行评议的期刊上。
NCT04523649。
