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Transient Electrocardiogram Assessment in Stroke Evaluation (TEASE)

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ClinicalTrials.gov Identifier: NCT03301662
Recruitment Status : Unknown
Verified September 2017 by Region Gävleborg.
Recruitment status was:  Not yet recruiting
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Region Gävleborg

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Stroke Diagnostic Test: chest and thumb- ECG

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transient Electrocardiogram Assessment in Stroke Evaluation
Estimated Study Start Date : October 9, 2017
Estimated Primary Completion Date : October 9, 2018
Estimated Study Completion Date : October 9, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Cumulative incidence of atrial arrhythmia [ Time Frame: 28 days (prospectively) ]
    Cumulative incidence of atrial arrhythmia at 28 days.


Secondary Outcome Measures :
  1. Previous atrial arrhythmia [ Time Frame: 10 years (retrospectively) ]
    The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy.

  2. Compliance with chest and thumb-ECG [ Time Frame: 28 days (prospectively) ]
    Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings).

  3. Patient-reported experience with chest and thumb-ECG [ Time Frame: 6 weeks (prospectively) ]
    Patient-reported experience with chest and thumb-ECG measured at week six

  4. Health-related Quality of Life [ Time Frame: 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.

  5. Cumulative incidence of stroke [ Time Frame: 3 years prospectively ]
    Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301662


Contacts
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Contact: Peter M Magnusson, MD 0705089407 ext +46 peter.magnusson@regiongavleborg.se
Contact: Gustav Mattsson, MD 0703122296 ext +46 gustav.mattsson@regiongavleborg.se

Sponsors and Collaborators
Region Gävleborg
Investigators
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Principal Investigator: Hirsh M Koyi, MD PhD Uppsala University/Region Gävleborg
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Gävleborg
ClinicalTrials.gov Identifier: NCT03301662    
Other Study ID Numbers: 2017321
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Gävleborg:
atrial fibrillation
cryptogenic stroke
ECG screening
health-related quality of life
Short Form-36
stroke
thumb-ECG
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes