An interventional study of Single lead ECG device and 7-Day Holter monitor. in Atrial Fibrillation, Ischemic Stroke and Transient Ischemic Attack, sponsored by Leiden University. Terminated at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Leiden University · Not applicable, Interventional, and Diagnostic
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 57 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Leiden University is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke.
Exclusion Criteria:
This arm will receive a 7-Day Holter monitor directly after randomization.
Device: 7-Day Holter monitor.
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.
The Holter is a conventional 7-Day Holter monitor.
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
Plan to share: Undecided
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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