Transient Electrocardiogram Assessment in Stroke Evaluation "TEASE"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Chest and thumb- ECG Diagnostic Test
    Intervention Desc: chest and thumb- ECG using the Coala Heart Monitor

Trial Population

Patients with a clinically confirmed diagnosis of ischemic stroke will be recruited from the catchment area of Region Gävleborg, Sweden. Eligible patients will be identified from daily checks of the medical records in the stroke unit. The recruitment is planned to start in October 2017.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cumulative incidence of atrial arrhythmia 28 days (prospectively)
Secondary Previous atrial arrhythmia 10 years (retrospectively)
Secondary Compliance with chest and thumb-ECG 28 days (prospectively)
Secondary Patient-reported experience with chest and thumb-ECG 6 weeks (prospectively)
Secondary Health-related Quality of Life 12 months prospectively
Secondary Cumulative incidence of stroke 3 years prospectively

Sponsors