Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial
机构:[1]Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong[2]Neurology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong[3]Department of Medicine, Centro Hospitalar Conde de S.o Januário, Macau, Macau, China[4]Department of Cardiology, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China广东省人民医院[5]Department of Cardiology, Kiang Wu Hospital, Macau, Macau, China[6]Department of Echocardiography & Non-invasive Cardiology Laboratory, Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China四川省人民医院[7]Department of Ultrasound in Medicine, Sichuan Provincial People’s Hospital Affiliated Wenjiang Hospital, Chengdu, China四川省人民医院[8]Department of Cardiology, Zhuhai People’s Hospital, Zhuhai, China[9]Department of Cardiology, People's Hospital of Yangjiang, Yangjiang, Guangdong, China[10]Department of Cardiology, Dongguan TCM Hospital, Dongguan, China[11]Department of Cardiology, Maoming People's Hospital, Guangdong, China[12]Department of Cardiology, Union Shenzhen Hospital, Huazhong University of Science and Technology, Shenzhen, China深圳市康宁医院深圳市南山区人民医院深圳医学信息中心[13]Medical Imaging Key Laboratory, Affiliated Hospital of North Sichuan Medical College, Sichuan, China[14]Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong
Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
基金:
Department of science and
Technology of Sichuan Province (2020YFH0183).
第一作者机构:[1]Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong
通讯作者:
推荐引用方式(GB/T 7714):
Chun Ka Wong,Jo Jo Hai,Yuk-Ming Lau,et al.Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial[J].BMJ OPEN.2022,12(7):doi:10.1136/bmjopen-2021-053466.
APA:
Chun Ka Wong,Jo Jo Hai,Yuk-Ming Lau,Mi Zhou,Hin-Wai LUI...&Chung-Wah Siu.(2022).Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial.BMJ OPEN,12,(7)
MLA:
Chun Ka Wong,et al."Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial".BMJ OPEN 12..7(2022)