Vol 25, No 1 (2018)
Original articles — Clinical cardiology
Published online: 2017-08-24

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Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study

Paweł Balsam1, Piotr Lodziński1, Agata Tymińska1, Krzysztof Ozierański1, Łukasz Januszkiewicz1, Renata Główczyńska1, Katarzyna Wesołowska2, Michał Peller1, Radosław Pietrzak3, Tomasz Książczyk3, Sonia Borodzicz1, Łukasz Kołtowski1, Mariusz Borkowski4, Bożena Werner3, Grzegorz Opolski1, Marcin Grabowski1
Pubmed: 28840587
Cardiol J 2018;25(1):52-59.

Abstract

Background: Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system.

Methods: An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device.

Discussion: The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations.

Trial registration: This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52–59)

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