Atrial Fibrillation, Stroke
Conditions
Keywords
atrial fibrillation, cryptogenic stroke, ECG screening, health-related quality of life, Short Form-36, stroke, thumb-ECG
Brief summary
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.
Interventions
DIAGNOSTIC_TESTchest and thumb- ECG
chest and thumb- ECG using the Coala Heart Monitor
Sponsors
Region Gävleborg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of atrial arrhythmia | 28 days (prospectively) | Cumulative incidence of atrial arrhythmia at 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Previous atrial arrhythmia | 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 | 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 | 6 weeks (prospectively) | Patient-reported experience with chest and thumb-ECG measured at week six |
| Health-related Quality of Life | 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 | 3 years prospectively | Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation. |
Contacts
Primary ContactPeter M Magnusson, MD
Backup ContactGustav Mattsson, MD
Outcome results
None listed