Transient Electrocardiogram Assessment in Stroke Evaluation

Region Gävleborg100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Atrial Fibrillation Stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Cumulative incidence of atrial arrhythmia

Cumulative incidence of atrial arrhythmia at 28 days.

Time frame: 28 days (prospectively)

Secondary Outcomes

Previous atrial arrhythmia

The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy.

Time frame: 10 years (retrospectively)

Compliance with chest and thumb-ECG

Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings).

Time frame: 28 days (prospectively)

Patient-reported experience with chest and thumb-ECG

Patient-reported experience with chest and thumb-ECG measured at week six

Time frame: 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.

Time frame: 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.

Time frame: 3 years prospectively