Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial
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...
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BMJ Publishing Group
2022-07-01
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| author | Jing Tan Yan Liang Yong Liu Wei Jiang Duo Huang Ning Tan Chung-Wah Siu Jo Jo Hai Xiaoyu Huang Jianfeng Ye Ji-yan Chen Chun Ka Wong Mi Zhou Li-Xue Yin Ming-Liang Zuo Kui Kai Lau Zhen Lei Yingqing Feng Bryan P Yan Wen-Sheng Yue Wen-Jun Zhang Yuk-Ming Lau Hin-Wai LUI Koon-Ho Chan Toi Meng Mok Weng-Chio Tam Kun-Chong Tam Xiuhua Feng Xiaofei Jiang Guanming Tan Mario Alberto Evora |
| author_facet | Jing Tan Yan Liang Yong Liu Wei Jiang Duo Huang Ning Tan Chung-Wah Siu Jo Jo Hai Xiaoyu Huang Jianfeng Ye Ji-yan Chen Chun Ka Wong Mi Zhou Li-Xue Yin Ming-Liang Zuo Kui Kai Lau Zhen Lei Yingqing Feng Bryan P Yan Wen-Sheng Yue Wen-Jun Zhang Yuk-Ming Lau Hin-Wai LUI Koon-Ho Chan Toi Meng Mok Weng-Chio Tam Kun-Chong Tam Xiuhua Feng Xiaofei Jiang Guanming Tan Mario Alberto Evora |
| author_sort | Jing Tan |
| collection | DOAJ |
| description | 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.Trial registration number NCT04523649. |
| format | Article |
| id | doaj-art-56795e3afbb245cd95d5c452143ec20a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-56795e3afbb245cd95d5c452143ec20a2025-01-31T16:55:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-053466Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trialJing Tan0Yan Liang1Yong Liu2Wei Jiang3Duo Huang4Ning Tan5Chung-Wah Siu6Jo Jo Hai7Xiaoyu Huang8Jianfeng Ye9Ji-yan Chen10Chun Ka Wong11Mi Zhou12Li-Xue Yin13Ming-Liang Zuo14Kui Kai Lau15Zhen Lei16Yingqing Feng17Bryan P Yan18Wen-Sheng Yue19Wen-Jun Zhang20Yuk-Ming Lau21Hin-Wai LUI22Koon-Ho Chan23Toi Meng Mok24Weng-Chio Tam25Kun-Chong Tam26Xiuhua Feng27Xiaofei Jiang28Guanming Tan29Mario Alberto Evora3028 State Key Laboratory of Oncology, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, ChinaFudan University School of Nursing, Shanghai, Shanghai, China2 Shenzhen Hospital of Southern Medical University, Shenzhen, Guangdong, ChinaDepartment of Cardiology, Union Shenzhen Hospital, Huazhong University of Science and Technology, Shenzhen, ChinaCardiology Division, Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, ChinaDepartment of Cardiology, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, ChinaCardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongCardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongDepartment of Cardiology, People`s Hospital of Yangjiang, Yangjiang, Guangdong, ChinaDepartment of Cardiology, Dongguan TCM Hospital, Dongguan, ChinaDepartment of Cardiology, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, ChinaCardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongCardiology Division, Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, ChinaDepartment of Echocardiography & Non-invasive Cardiology Laboratory, Sichuan Academy of Medical Sciences and Sichuan People`s Hospital, Chengdu, Sichuan, ChinaDepartment of Echocardiography & Non-invasive Cardiology Laboratory, Sichuan Academy of Medical Sciences and Sichuan People`s Hospital, Chengdu, Sichuan, ChinaNeurology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongDepartment of Cardiology, Union Shenzhen Hospital, Huazhong University of Science and Technology, Shenzhen, ChinaDepartment of Cardiology, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, ChinaDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong KongMedical Imaging Key Laboratory, Affiliated Hospital of North Sichuan Medical College, Sichuan, ChinaDepartment of Ultrasound in Medicine, Sichuan Provincial People’s Hospital Affiliated Wenjiang Hospital, Chengdu, ChinaCardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongCardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongNeurology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong KongDepartment of Medicine, Centro Hospitalar Conde de São Januário, Macau, Macau, ChinaDepartment of Medicine, Centro Hospitalar Conde de São Januário, Macau, Macau, ChinaDepartment of Cardiology, Kiang Wu Hospital, Macau, Macau, ChinaDepartment of Cardiology, Kiang Wu Hospital, Macau, Macau, ChinaDepartment of Cardiology, Zhuhai People’s Hospital, Zhuhai, ChinaDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong KongDepartment of Medicine, Centro Hospitalar Conde de São Januário, Macau, Macau, ChinaIntroduction 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.Trial registration number NCT04523649.https://bmjopen.bmj.com/content/12/7/e053466.full |
| spellingShingle | Jing Tan Yan Liang Yong Liu Wei Jiang Duo Huang Ning Tan Chung-Wah Siu Jo Jo Hai Xiaoyu Huang Jianfeng Ye Ji-yan Chen Chun Ka Wong Mi Zhou Li-Xue Yin Ming-Liang Zuo Kui Kai Lau Zhen Lei Yingqing Feng Bryan P Yan Wen-Sheng Yue Wen-Jun Zhang Yuk-Ming Lau Hin-Wai LUI Koon-Ho Chan Toi Meng Mok Weng-Chio Tam Kun-Chong Tam Xiuhua Feng Xiaofei Jiang Guanming Tan Mario Alberto Evora Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial BMJ Open |
| title | Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial |
| title_full | Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial |
| title_fullStr | Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial |
| title_full_unstemmed | Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial |
| title_short | Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial |
| title_sort | protocol for home based solution for remote atrial fibrillation screening to prevent recurrence stroke hua tuo af trial a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e053466.full |
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