Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation (MOBILE-AF)

The main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke; Atrial Fibrillation; Transient Ischemic Attack
• Intervention / Treatment: Device: 7-Day Holter monitor.; Device: Single lead ECG device

Detailed Description

Rationale: A standard work-up of stroke patients to identify a cause of stroke consists of Computed Tomography (CT), CT angiography of head and neck arteries, transthoracic echocardiography, 12-lead 10-seconds electrocardiogram (ECG), blood tests and 24-hour ECG monitoring. A stroke is called "cryptogenic" if no cause can be determined after standard work-up. Current detection of atrial fibrillation (AF) after stroke is 2.0%. Recent studies revealed that prolonged monitoring yields higher percentages of detected AF (12.0%). Devices used in these trials suffer from drawbacks. The investigators' hypothesis is that a new, smartphone compatible device, producing a single lead ECG (single lead ECG device), can be used for prolonged ECG monitoring in cryptogenic stroke patients.

Objective: The main objective of this study is to compare the incidence of detected AF in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.

Study design: A multicenter randomized trial. Study population: Cryptogenic stroke patients admitted to a hospital participating in the study. The calculated sample size is 200 (100 per arm).

Intervention: After inclusion, patients will be randomized to either a single lead ECG device or a 7-Day Holter Monitor.

Main study parameters/endpoints: The main endpoint will be the percentage of detected atrial fibrillation in both the single lead ECG device group and the 7-Day Holter group after one year.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both devices are battery powered and electrically safe. Patients face a 2-3% risk that AF is detected false-positively; this might lead to incorrect oral anticoagulation (OAC) prescription. However, a potential benefit of the investigators' study is that if AF is detected and treated with OAC, this significantly reduces the chance of recurrent stroke.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Regionshospitalet Midtjylland
• Netherlands
  • Zuid-Holland
    • Delft, Zuid-Holland, Netherlands
      • Reinier de Graaf Hospital
    • Den Haag, Zuid-Holland, Netherlands, 2512 VA
      • Medisch Centrum Haaglanden
    • Den Haag, Zuid-Holland, Netherlands, 2597 AX
      • Bronovo Ziekenhuis
    • Gouda, Zuid-Holland, Netherlands, 2803 HH
      • Groene Hart Ziekenhuis
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center
    • Leiderdorp, Zuid-Holland, Netherlands, 2353 GA
      • Alrijne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke.

  • Ischemic stroke is defined as an episode of transient or neurological dysfunction caused by focal brain or retinal ischemia with recent infarction on imaging
  • A TIA is defined as transient episode of neurologic dysfunction typically lasting less than one hour caused by focal brain or retinal ischemia without recent infarction on imaging.

Exclusion Criteria:

• Known etiology of TIA or ischemic stroke
• TIA or stroke caused by spinal ischemia
• TIA only presenting with non-localising symptoms
• Uncertainty about the diagnosis of TIA because of unclear clinical symptoms
• Myocardial infarction <6 months before stroke
• Coronary Artery Bypass Grafting <6 months before stroke
• Severe valvular heart disease
• Documented history of atrial fibrillation or atrial flutter
• Permanent indication for oral anticoagulation at enrolment
• Patient has permanent OAC contraindication
• Patient is included in another randomized trial
• Left ventricular aneurysm on echocardiography
• Thrombus on echocardiographyRenal dysfunction (creatinine clearance <30 mL/min/1.73m2)
• Patient has life expectancy of <1 year
• Patient is not willing to sign the informed consent form
• Patient is <18 years of age
• Patient is considered an incapacitated adult
• Patient is not in possession of a smartphone with Android Operating System (OS) or iOS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 7-Day Holter monitor; This arm will receive a 7-Day Holter monitor directly after randomization.	Device: 7-Day Holter monitor.; The Holter is a conventional 7-Day Holter monitor.
Experimental: Single lead ECG device; This arm will be asked to take a single lead ECG two times per day and in case of complaints with a single lead ECG device.	Device: Single lead ECG device; The single lead ECG device is a smartphone compatible handheld device that produces a single lead ECG after 30 seconds of measurement. It is non-invasive, electrically safe and easy to use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of detected atrial fibrillation	1 year of follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL	24 hours after cryptogenic stroke
Percentages of atrial ectopy detected on 7-Day Holter monitor	7 days after cryptogenic stroke
Left atrial diameter in cm/m2	24 hours after cryptogenic stroke
Number of participants with a recurrent stroke or TIA as defined in the trial	Within one year after cryptogenic stroke
Number of participants with a major bleeding	Within one year after cryptogenic stroke
Left atrial volume in mL/m2	24 hours after cryptogenic stroke

Collaborators and Investigators

• Sponsor: Leiden University
• Collaborators: Herning Hospital; Medical Center Haaglanden; Groene Hart Ziekenhuis; Reinier de Graaf Groep; Alrijne Hospital
• Investigators: Principal Investigator: Serge Trines, MD, PhD, Leiden University Medical Center

Publications and helpful links

General Publications

• Treskes RW, Gielen W, Wermer MJ, Grauss RW, van Alem AP, Dehnavi RA, Kirchhof CJ, van der Velde ET, Maan AC, Wolterbeek R, Overbeek OM, Schalij MJ, Trines SA. Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial. Trials. 2017 Aug 29;18(1):402. doi: 10.1186/s13063-017-2131-0.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2016
• Primary Completion (Actual): January 4, 2022
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient; Atrial Fibrillation
• Other Study ID Numbers: MOBILE-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided