Abstract
BackgroundRecently 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.MethodsFor 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.DiscussionThe 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 registrationClinicalTrials.gov, ID: NCT02507986. Registered on 15 July 2015.
Highlights
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
Study outcomes 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
The MOBILE-AF trial is an international, multicentre, randomised clinical trial that evaluates the efficacy of the Kardia Mobile device in the detection of AF in cryptogenic stroke and TIA patients
Summary
Patient population For this study, patients with cryptogenic stroke or TIA who have been treated at one of the participating centres (see the list in Additional file 1) will be asked to participate. Randomisation and follow-up The Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection trial (MOBILE-AF) is an international multicentre (a list of the six participating centres can be found in Additional file 1), randomised, open clinical trial, registered under clinical trial numbers NCT02507986 (https://www.clinicaltrials.gov/) and NL54103.058.15 (https://www.toetsingonline.nl/ ), in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (in Additional file 2). It randomises patients, after inclusion, to follow-up with either the Kardia Mobile (intervention group) or the 7-day Holter monitor (control group). They will be instructed by a dedicated PhD student about the usage of the Kardia Mobile, including downloading the app, setting up an account and recording an ECG with the Kardia Mobile device. Pro-B-type natriuretic peptide (BNP) levels in all patients within 24 h after cryptogenic stroke
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