Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2131-0) contains supplementary material, which is available to authorized users.

Kardia Mobile applicability in clinical practice: A comparison of Kardia Mobile and standard 12-lead electrocardiogram records in 100 consecutive patients of a tertiary cardiovascular care center

“…According to available research, this is the first study to investigate and compare selected parameters in KM records and conventional 12lead ECGs. New studies, currently with protocols available [9,10] will shortly verify the usefulness of the method and the present findings.…”

Smartphone electrocardiogram monitoring: current perspectives

“…The primary outcome will be the percentage of patients identified as having new AF. 16 The first data are expected in 2019. The ultimate application of this clinical trial's results will rest on patient adherence to twice-daily smartphone ECG monitoring for an entire year.…”

Smart and simple

“…serung der Detektion von Herzrhythmusstörungen ermöglicht [15][16][17] [19]. Die aktuell noch laufende MOBILE-AF-Studie evaluiert den diagnostischen Stellenwert des Kardia EKG Monitor gegenüber einem implantierten Ereignisrekorder hinsichtlich der Detektion von Vorhofflimmern bei Patienten mit kryptogenem Schlaganfall [20]. Die Ergebnisse dieser Studie könnten einen Hinweis darauf geben, ob zukünftig mobile Applikationen bei selektierten Patienten die Implantation eines kontinuierlichen Rhythmusmonitors ersetzen können.…”