Key result
MOBILE-AF tests whether smartphone ECG improves AF detection vs 7-day Holter after cryptogenic stroke.
Why the study?
Prolonged ECG monitoring may improve detection of paroxysmal AF in cryptogenic stroke or TIA patients, but the effectiveness of smartphone-compatible single-lead ECG devices is not established.
Does a smartphone-compatible ECG device improve atrial fibrillation detection compared to a 7-day Holter monitor in patients with cryptogenic stroke or TIA?
RCT (n=200)
Open-label
Block randomization, stratified per centre and per diagnosis
Yes
Does a smartphone-compatible ECG device improve atrial fibrillation detection compared to a 7-day Holter monitor in patients with cryptogenic stroke or TIA?
The MOBILE-AF trial protocol outlines a study to determine if a smartphone-based ECG device used twice daily for a year is more effective than a 7-day Holter monitor for detecting atrial fibrillation in patients with cryptogenic stroke or TIA.
BACKGROUND: Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolonged ECG monitoring is a smartphone-compatible ECG device (Kardia Mobile, Alivecor, San Francisco, CA, USA) that allows the patient to record a single-lead ECG without the presence of trained health care staff. The MOBILE-AF trial will investigate the effectiveness of the ECG device for AF detection in patients with cryptogenic stroke or TIA. In this paper, the rationale and design of the MOBILE-AF trial is presented. METHODS: For this international, multicentre trial, 200 patients with cryptogenic stroke or TIA will be randomised. One hundred patients will receive the ECG device and will be asked to record their ECG twice daily during a period of 1 year. One hundred patients will receive a 7-day Holter monitor. DISCUSSION: The primary outcome of this study is the percentage of patients in which AF is detected in the first year after the index ischaemic stroke or TIA. Secondary outcomes include markers for AF prediction, orally administered anticoagulation therapy changes, as well as the incidence of recurrent stroke and major bleeds. First results can be expected in mid-2019. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02507986 . Registered on 15 July 2015.
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Treskes et al. (2017) conducted an RCT in Cryptogenic stroke or TIA (n=200). Kardia Mobile (smartphone-compatible ECG device) vs. 7-day Holter monitor was evaluated on Percentage of patients in which atrial fibrillation is detected in the first year after the index ischaemic stroke or TIA. The MOBILE-AF trial will evaluate whether a smartphone-compatible ECG device improves the detection of atrial fibrillation over 1 year compared to a 7-day Holter monitor in 200 patients with cryptogenic stroke or TIA.
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