Transient Electrocardiogram Assessment in Stroke Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October 2017. Patients with a history of ischemic stroke without documented atrial fibrillation before or during ECG evaluation in the stroke unit will be evaluated by the chest and thumb-ECG system Coala Heart Monitor. The monitoring system is connected to a smart phone application which allows for remote monitoring and prompt advice on clinical management. Over a period of 28 days, patients will be monitored twice daily and may activate the ECG recording at symptoms. Upon completion, the system is returned by mail. This system offers a possibility to evaluate the presence of atrial fibrillation post-stroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. In addition Health-related Quality of Life using Short Form-36 in comparison to Swedish population norms will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a self-developed questionnaire.

Official Title
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Transient Electrocardiogram Assessment in Stroke Evaluation

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Diagnostic Test: chest and thumb- ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, aged ≥18 years, with a validated diagnosis of ischemic cryptogenic stroke are eligible for the study. Exclusion Criteria: For screening with chest and thumb-ECG, exclusion criteria are as follows: previously known atrial arrhythmia with an indication for anticoagulation, implantable defibrillator, pacemaker or insertable cardiac monitor, pregnancy, permanent indication for anticoagulation (including low-molecular weight heparin) due to atrial arrhythmia, mechanical heart valve, deep vein thrombosis, or pulmonary embolism. Patients with a life expectancy ≤6 months (e.g. severe heart failure New York Heart Association functional class IV or malignancy) are likewise excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: chest and thumb- ECG|chest and thumb- ECG using the Coala Heart Monitor|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of atrial arrhythmia | Cumulative incidence of atrial arrhythmia at 28 days. | 28 days (prospectively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Previous atrial arrhythmia | The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy. | 10 years (retrospectively) | 
| Compliance with chest and thumb-ECG | Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings). | 28 days (prospectively) | 
| Patient-reported experience with chest and thumb-ECG | Patient-reported experience with chest and thumb-ECG measured at week six | 6 weeks (prospectively) | 
| Health-related Quality of Life | 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. | 12 months prospectively | 
| Cumulative incidence of stroke | Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation. | 3 years prospectively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, cryptogenic stroke, ECG screening, health-related quality of life, Short Form-36, stroke, thumb-ECG