Transient Electrocardiogram Assessment in Stroke Evaluation (TEASE)

September 29, 2017 updated by: Region Gävleborg

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of atrial arrhythmia
Time Frame: 28 days (prospectively)
Cumulative incidence of atrial arrhythmia at 28 days.
28 days (prospectively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years (retrospectively)
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).
28 days (prospectively)
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
6 weeks (prospectively)
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.
12 months prospectively
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.
3 years prospectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Gävleborg

Investigators

  • Principal Investigator: Hirsh M Koyi, MD PhD, Uppsala University/Region Gävleborg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 9, 2017

Primary Completion (Anticipated)

October 9, 2018

Study Completion (Anticipated)

October 9, 2019

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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