Key result
Ongoing RCT tests home-based ECG screening for atrial fibrillation detection in stroke survivors.
Why the study?
Current guidelines recommend ECG monitoring post-ischaemic stroke to detect AF and prevent recurrence, but optimal detection strategies and downstream management remain to be established.
Does home-based single-lead ECG screening improve the detection of atrial fibrillation and prevent stroke recurrence in adults with a history of ischemic stroke?
RCT (n=1,740)
Open-label with blinded endpoint adjudication
1:1 ratio, permuted blocks of four, stratified by time from index stroke and study site
Yes
Does home-based single-lead ECG screening improve the detection of atrial fibrillation and prevent stroke recurrence in adults with a history of ischemic stroke?
This trial protocol outlines a study to determine if home-based smartphone-enabled ECG monitoring can effectively detect new-onset atrial fibrillation to prevent stroke recurrence in high-risk patients.
No results yet from this RCT protocol; leaves open whether home-based AF screening improves detection or prevents recurrent stroke in survivors.
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.
No takes yet. Share an insight, caveat, or question.
Wong et al. (2022) conducted an RCT in Ischemic stroke (n=1,740). Home-based AF screening with single-lead ECG vs. Conventional care was evaluated on Time to first detection of atrial fibrillation at 24 months of follow-up. Home-based AF screening efficacy for detecting atrial fibrillation in stroke survivors is currently under investigation in this clinical trial protocol, yielding no quantitative results yet.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: