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

Roderick W Treskes, Willem Gielen, Marieke J Wermer, Robert W Grauss, Anouk P van Alem, Reza Alizadeh Dehnavi, Charles J Kirchhof, Enno T van der Velde, Arie C Maan, Ron Wolterbeek, Onno M Overbeek, Martin J Schalij, Serge A Trines, Roderick W Treskes, Willem Gielen, Marieke J Wermer, Robert W Grauss, Anouk P van Alem, Reza Alizadeh Dehnavi, Charles J Kirchhof, Enno T van der Velde, Arie C Maan, Ron Wolterbeek, Onno M Overbeek, Martin J Schalij, Serge A Trines

Abstract

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.

Conflict of interest statement

Authors’ information

RT is a PhD student in e-Health in cardiology. WG, RG, AA, RD, CK, MS and ST are all consultant cardiologists. MW and OO are consultant neurologists. EV is a clinical physicist. AM is the supervisor of the Holter service. RW is a biostatistician.

Ethics approval and consent to participate

This protocol (version 1, 02-10-2015, P15.289) was approved by the Medical Ethics Committee (MEC) of the Leiden University Medical Centre. Protocol changes will first need approval from the MEC before they can be implemented in the trial. All study subjects will provide written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
An electrocardiogram (ECG) recorded by the AliveCor device showing sinus rhythm
Fig. 2
Fig. 2
An electrocardiogram (ECG) recorded by the AliveCor device showing atrial fibrillation
Fig. 3
Fig. 3
Flowchart of study design
Fig. 4
Fig. 4
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure: schedule of enrolment, interventions and assessments

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