Transient Electrocardiogram Assessment in Stroke Evaluation

Stroke Clinical Trial

— TEASE  

Official title:

Transient Electrocardiogram Assessment in Stroke Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03301662
• Other study ID #: 2017321
• Status: Not yet recruiting
• Phase: N/A
• First received: September 29, 2017
• Last updated: September 29, 2017
• Start date: October 9, 2017
• Est. completion date: October 9, 2019

Study information

• Verified date: September 2017
• Source: Region Gävleborg
• Contact: Peter M Magnusson, MD
• Phone: 0705089407
• Email: peter.magnusson[@]regiongavleborg.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Gävleborg

References & Publications (7)

Andersson T, Magnuson A, Bryngelsson IL, Frøbert O, Henriksson KM, Edvardsson N, Poçi D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 — View Citation

Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. — View Citation

Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Counc — View Citation

Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Ca — View Citation

Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrill — View Citation

Schnabel RB, Yin X, Gona P, Larson MG, Beiser AS, McManus DD, Newton-Cheh C, Lubitz SA, Magnani JW, Ellinor PT, Seshadri S, Wolf PA, Vasan RS, Benjamin EJ, Levy D. 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in — View Citation

Själander S, Själander A, Svensson PJ, Friberg L. Atrial fibrillation patients do not benefit from acetylsalicylic acid. Europace. 2014 May;16(5):631-8. doi: 10.1093/europace/eut333. Epub 2013 Oct 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of atrial arrhythmia	Cumulative incidence of atrial arrhythmia at 28 days.	28 days (prospectively)
Secondary	Previous atrial arrhythmia	The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy.	10 years (retrospectively)
Secondary	Compliance with chest and thumb-ECG	Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings).	28 days (prospectively)
Secondary	Patient-reported experience with chest and thumb-ECG	Patient-reported experience with chest and thumb-ECG measured at week six	6 weeks (prospectively)
Secondary	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.	12 months prospectively
Secondary	Cumulative incidence of stroke	Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation.	3 years prospectively