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Published on: February 26, 2013
Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF
Chun Ka Wong1, Jo Jo Hai1, Yuk-Ming Lau1
1Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong.
Insights
This study investigates long-term home-based ECG monitoring for detecting atrial fibrillation (AF) after stroke. Early AF detection aims to prevent recurrent strokes, improving patient outcomes.
Area of Science:
- Cardiology and Neurology
- Medical Technology and Digital Health
Background:
- International guidelines recommend ECG monitoring post-ischaemic stroke to detect atrial fibrillation (AF) and prevent recurrence.
- Optimal AF detection strategies and subsequent management for stroke prevention require further investigation.
Purpose of the Study:
- To explore the efficacy of long-term, home-based ECG monitoring for AF detection in stroke patients.
- To assess the impact of this strategy on preventing stroke recurrence over a 24-month period.
Main Methods:
- Prospective, randomized, open-label trial with blinded endpoint adjudication.
- Patients with a history of ischaemic stroke stratified by time since event (<1, 1-3, >3 years).
- Intervention group uses a handheld ECG device and smartphone app for daily/symptomatic recording; data analyzed by AI. Control group receives standard care.
Main Results:
- Primary endpoint: Time to first AF detection at 24 months.
- Secondary endpoints: Recurrent stroke/TIA, anticoagulation initiation, heart failure hospitalization, cardiovascular death, all-cause death.
Conclusions:
- The study aims to establish the effectiveness of a novel home-based AF screening system.
- Findings will inform clinical practice regarding AF detection and stroke prevention strategies.
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.
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