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.
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.
- 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.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Diagnostic
- Intervention: Parallel Assignment
|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|