Stroke Clinical Trial
Official title:
Novel Methods for Arrhythmia Detection: Chest Strap ECG and Wrist Band Photoplethysmography Compared to Holter-device for Atrial Fibrillation Detection
NCT number | NCT03721601 |
Other study ID # | KUH507E015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | September 30, 2017 |
Verified date | November 2018 |
Source | Kuopio University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a
significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making
its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by
12-lead electrocardiogram (ECG) or any other ECG-strip.
The aim of the study is to assess the potential of chest strap as an ECG monitor, especially
in arrhythmia detection by cardiologist and algorithm.
Status | Completed |
Enrollment | 220 |
Est. completion date | September 30, 2017 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Atrial fibrillation in 12-lead ECG Exclusion Criteria: - body mass index (BMI) over 33 - implanted pacemaker device - 12-lead ECG findings of left bundle branch block (LBBB) or right bundle branch block (RBBB) - medical condition requiring immediate treatment that would be delayed by the study measurements - serious infectious disease |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University hospital | Helsinki | |
Finland | North Carelia central hospital | Joensuu | |
Finland | Kuopio University Hospital | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital |
Finland,
Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LÅ, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693. Review. — View Citation
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castellá M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. English, Spanish. Erratum in: Rev Esp Cardiol (Engl Ed). 2017 Nov;70(11):1031. — View Citation
Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. Review. Erratum in: Europace. 2018 Apr 1;20(4):658. — View Citation
Nemati S, Ghassemi MM, Ambai V, Isakadze N, Levantsevych O, Shah A, Clifford GD. Monitoring and detecting atrial fibrillation using wearable technology. Conf Proc IEEE Eng Med Biol Soc. 2016 Aug;2016:3394-3397. doi: 10.1109/EMBC.2016.7591456. — View Citation
Thijs V. Atrial Fibrillation Detection: Fishing for An Irregular Heartbeat Before and After Stroke. Stroke. 2017 Oct;48(10):2671-2677. doi: 10.1161/STROKEAHA.117.017083. Epub 2017 Sep 15. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chest strap and PPG-device data quality | Sensitivity and positive predictive value for the beat detection of chest strap ECG and PPG measurements and sensitivity and specificity for the atrial fibrillation detection | 5 minutes | |
Secondary | Chest strap and PPG-device data quality to enable arrhythmia diagnosis | Sensitivity and Specificity for the atrial fibrillation detection of chest strap ECG and PPG measurements. | 5 minutes |
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