Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation (MOBILE-AF)
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|ClinicalTrials.gov Identifier: NCT02507986|
Recruitment Status : Suspended (no personnel for recruitment)
First Posted : July 24, 2015
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Ischemic Stroke Transient Ischemic Attack||Device: Single lead ECG device Device: 7-Day Holter monitor.||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
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.
- Percentage of detected atrial fibrillation [ Time Frame: 1 year of follow-up ]
- Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL [ Time Frame: 24 hours after cryptogenic stroke ]
- Percentages of atrial ectopy detected on 7-Day Holter monitor [ Time Frame: 7 days after cryptogenic stroke ]
- Left atrial diameter in cm/m2 [ Time Frame: 24 hours after cryptogenic stroke ]
- Number of participants with a recurrent stroke or TIA as defined in the trial [ Time Frame: Within one year after cryptogenic stroke ]
- Number of participants with a major bleeding [ Time Frame: Within one year after cryptogenic stroke ]
- Left atrial volume in mL/m2 [ Time Frame: 24 hours after cryptogenic stroke ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507986
|Herning, Denmark, 7400|
|Reinier de Graaf Hospital|
|Delft, Zuid-Holland, Netherlands|
|Medisch Centrum Haaglanden|
|Den Haag, Zuid-Holland, Netherlands, 2512 VA|
|Den Haag, Zuid-Holland, Netherlands, 2597 AX|
|Groene Hart Ziekenhuis|
|Gouda, Zuid-Holland, Netherlands, 2803 HH|
|Leiden University Medical Center|
|Leiden, Zuid-Holland, Netherlands, 2333 ZA|
|Leiderdorp, Zuid-Holland, Netherlands, 2353 GA|
|Principal Investigator:||Serge Trines, MD, PhD||Leiden University Medical Center|