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| Name | Class |
|---|---|
| Medical Center Haaglanden | OTHER |
| Groene Hart Ziekenhuis | OTHER |
| Herning Hospital | OTHER |
| Alrijne Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-Day Holter monitor | Active Comparator | This arm will receive a 7-Day Holter monitor directly after randomization. |
|
| Single lead ECG device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single lead ECG device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of detected atrial fibrillation | 1 year of follow-up |
| Measure | Description | 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 | |
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Inclusion Criteria:
Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge Trines, MD, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regionshospitalet Midtjylland | Herning | 7400 | Denmark | |||
| Reinier de Graaf Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28851409 | Derived | 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. |
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| OTHER |
| Reinier de Graaf Groep | OTHER |
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| 7-Day Holter monitor. | Device | The Holter is a conventional 7-Day Holter monitor. |
|
| 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 |
| Delft |
| South Holland |
| Netherlands |
| Groene Hart Ziekenhuis | Gouda | South Holland | 2803 HH | Netherlands |
| Leiden University Medical Center | Leiden | South Holland | 2333 ZA | Netherlands |
| Alrijne Hospital | Leiderdorp | South Holland | 2353 GA | Netherlands |
| Medisch Centrum Haaglanden | The Hague | South Holland | 2512 VA | Netherlands |
| Bronovo ziekenhuis | The Hague | South Holland | 2597 AX | Netherlands |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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