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

Recruiting

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Single lead ECG device Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Single lead ECG device
    Description: 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.
  • 7-Day Holter monitor. Device
    Intervention Desc: The Holter is a conventional 7-Day Holter monitor.
    ARM 1: Kind: Experimental
    Label: 7-Day Holter monitor
    Description: This arm will receive a 7-Day Holter monitor directly after cryptogenic stroke and approximately one year after cryptogenic stroke.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of detected atrial fibrillation 1 year of follow-up No
Secondary Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL 24 hours after cryptogenic stroke No
Secondary Percentages of atrial ectopy detected on 7-Day Holter monitor 7 days after cryptogenic stroke No
Secondary Left atrial diameter in cm/m2 24 hours after cryptogenic stroke No
Secondary Number of participants with a recurrent stroke or TIA as defined in the trial Within one year after cryptogenic stroke Yes
Secondary Number of participants with a major bleeding Witihin one year after cryptogenic stroke Yes
Secondary Left atrial volume in mL/m2 24 hours after cryptogenic stroke No

Sponsors