Transient Electrocardiogram Assessment in Stroke Evaluation (TEASE)
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|ClinicalTrials.gov Identifier: NCT03301662|
Recruitment Status : Unknown
Verified September 2017 by Region Gävleborg.
Recruitment status was: Not yet recruiting
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
In stroke survivors, atrial fibrillation is typically detected with short-term electrocardiogram (ECG) monitoring in the stroke unit. Prolonged continuous ECG monitoring is impractical and requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb-ECG could provide an alternative for atrial fibrillation detection post-stroke.
The primary objective of our study is to assess the incidence of newly diagnosed atrial fibrillation during 28 days of chest and thumb-ECG monitoring in patients with cryptogenic stroke. Secondary objectives are to assess Health-related Quality of Life using Short Form-36 and the feasibility of the Coala Heart Monitor in patients with stroke.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Stroke||Diagnostic Test: chest and thumb- ECG|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Transient Electrocardiogram Assessment in Stroke Evaluation|
|Estimated Study Start Date :||October 9, 2017|
|Estimated Primary Completion Date :||October 9, 2018|
|Estimated Study Completion Date :||October 9, 2019|
- Diagnostic Test: chest and thumb- ECG
chest and thumb- ECG using the Coala Heart Monitor
- Cumulative incidence of atrial arrhythmia [ Time Frame: 28 days (prospectively) ]Cumulative incidence of atrial arrhythmia at 28 days.
- Previous atrial arrhythmia [ Time Frame: 10 years (retrospectively) ]The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy.
- Compliance with chest and thumb-ECG [ Time Frame: 28 days (prospectively) ]Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings).
- Patient-reported experience with chest and thumb-ECG [ Time Frame: 6 weeks (prospectively) ]Patient-reported experience with chest and thumb-ECG measured at week six
- Health-related Quality of Life [ Time Frame: 12 months prospectively ]Health-related Quality of Life (Short Form-36) at week 6 and at 12 months and the association with atrial fibrillation and compliance with chest and thumb-ECG.
- Cumulative incidence of stroke [ Time Frame: 3 years prospectively ]Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation.
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): NCT03301662
|Contact: Peter M Magnusson, MD||0705089407 ext +firstname.lastname@example.org|
|Contact: Gustav Mattsson, MD||0703122296 ext +email@example.com|
|Principal Investigator:||Hirsh M Koyi, MD PhD||Uppsala University/Region Gävleborg|