Clinical trial NCT03301662: Transient Electrocardiogram Assessment in Stroke Evaluation
Official title: Transient Electrocardiogram Assessment in Stroke Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke
Keywords: atrial fibrillation
cryptogenic stroke
ECG screening
health-related quality of life
Short Form-36
stroke
thumb-ECG
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of atrial arrhythmia
timeFrame: 28 days (prospectively)
Secondary outcomes:
measure: Previous atrial arrhythmia
timeFrame: 10 years (retrospectively)
measure: Compliance with chest and thumb-ECG
timeFrame: 28 days (prospectively)
measure: Patient-reported experience with chest and thumb-ECG
timeFrame: 6 weeks (prospectively)
measure: Health-related Quality of Life
timeFrame: 12 months prospectively
measure: Cumulative incidence of stroke
timeFrame: 3 years prospectively
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University/Region Gävleborg
name: Hirsh M Koyi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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