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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chest and thumb- ECG | Diagnostic Test | chest and thumb- ECG using the Coala Heart Monitor |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of atrial arrhythmia | Cumulative incidence of atrial arrhythmia at 28 days. | 28 days (prospectively) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Compliance with chest and thumb-ECG |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter M Magnusson, MD | Contact | 0705089407 | +46 | peter.magnusson@regiongavleborg.se |
| Gustav Mattsson, MD | Contact | 0703122296 | +46 | gustav.mattsson@regiongavleborg.se |
| Name | Affiliation | Role |
|---|---|---|
| Hirsh M Koyi, MD PhD | Uppsala University/Region Gävleborg | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17577005 | Result | 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. doi: 10.7326/0003-4819-146-12-200706190-00007. | |
| 24315724 | Result | 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 fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 | Patient-reported experience with chest and thumb-ECG measured at week six | 6 weeks (prospectively) |
| 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 |
| 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 |
| 24788967 | Result | 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, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. |
| 24158253 | Result | Sjalander S, Sjalander 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. |
| 27567465 | Result | 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, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available. |
| 25960110 | Result | 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 the Framingham Heart Study: a cohort study. Lancet. 2015 Jul 11;386(9989):154-62. doi: 10.1016/S0140-6736(14)61774-8. Epub 2015 May 7. |
| 23321349 | Result | Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci 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 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14. |
| 33115891 | Derived | Magnusson P, Lyren A, Mattsson G. Patient-reported feasibility of chest and thumb ECG after cryptogenic stroke in Sweden: an observational study. BMJ Open. 2020 Oct 28;10(10):e037360. doi: 10.1136/bmjopen-2020-037360. |
| 32973062 | Derived | Magnusson P, Lyren A, Mattsson G. Diagnostic yield of chest and thumb ECG after cryptogenic stroke, Transient ECG Assessment in Stroke Evaluation (TEASE): an observational trial. BMJ Open. 2020 Sep 24;10(9):e037573. doi: 10.1136/bmjopen-2020-037573. |
| 29615448 | Derived | Magnusson P, Koyi H, Mattsson G. A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden. BMJ Open. 2018 Apr 3;8(4):e019933. doi: 10.1136/bmjopen-2017-019933. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |