Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
220 participants
OBSERVATIONAL
2017-06-15
2018-12-31
Brief Summary
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Detailed Description
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ECG platform The system consists of biomedical shirt, electronic device and ECG software. The biomedical shirt captures the electrocardiographic signal via the textile electrodes integrated into the garment. The biomedical shirt enable non-invasive reception of a medical-quality ECG signal through adherence of textile electrodes to the skin. The biomedical shirt-ECG monitoring is based on BlendFix® sensor electrode technology that is capable of being used in real-time and for continuous recording. To the shirt is attached the electronic device that transmits the ECG signal (as well as other signals including accelerometer and GPS) via bluetooth to a computer and stores the information in memory cards. The software allows the visualisation and analysis of data such as ECG, heart rate, activity index and relative position of the body captured by the electronic device. The platform is a medical device certified in the European Union that has been tested in patients who underwent an exercise echocardiography test.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 18 - 70 years old
* \> 18 years old
* Meeting the current European Society of Cardiology Guidelines indications for CRT implantation (including upgrades)
* Patients within 3 months after myocardial infarction, after completed early post-infarction ambulatory cardiac rehabilitation
* Signed written informed consent
* 18 - 80 years old
* 5-18 years old
* Patients with diagnosed SVT qualified to EPS
* Signed written informed consent
Exclusion Criteria
* Chronic inflammatory disease, severe chronic kidney disease,
* Active cancer, and a period of 5 years from the end of treatment
* Use of antiarrhythmic agents after PVI
* Persistent AF
* Previous PVI
* The size of the chest that prevents wearing biomedical shirt
* Contraindications to wear biomedical shirt (structural disease of the chest, skin diseases, allergy for materials used in ECG shirts)
CRT recipients
* Chest size which make impossible to wear nECG shirt
* Contraindications to wear biomedical shirt (structural disease of the chest, skin diseases, allergy for materials used in ECG shirts)
Patients during cardiac rehabilitation after myocardial infarction
* Dysfunction of the lower limbs or other walking impairments,
* Age below 18 or over 80 years old.
* Unstable angina pectoris.
* Life-threatening arrhythmias.
* Decompensated congestive heart failure.
* Left ventricular ejection fraction \<35%.
* Dissecting aneurysm of the aorta.
* Acute myocardial infarction.
* Vein thrombophlebitis.
* Pulmonary or peripheral embolism.
* Uncontrolled hypertension.
* Active inflammation.
* Other contraindication to physical activity.
* The state after the pacemaker or implantable cardioverter-defibrillator implantation (contraindication to bioelectrical impedance measurement).
* Persistent AF
* Previous PVI
Pediatric patients with SVT
* BMI ≥35 kg/m2
* Chronic inflammatory disease, severe chronic kidney disease,
* Active cancer, and a period of 5 years from the end of treatment
* The size of the chest that prevents wearing biomedical shirt
* Contraindications to wear biomedical shirt (structural disease of the chest, skin diseases, allergy for materials used in ECG shirts)
5 Years
100 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Marcin Grabowski
Clinical Professor
Principal Investigators
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Renata Główczyńska, PhD
Role: PRINCIPAL_INVESTIGATOR
1st Department of Cardiology Medical University of Warsaw
Paweł Balsam, PhD
Role: PRINCIPAL_INVESTIGATOR
1st Department of Cardiology Medical University of Warsaw
Piotr Lodziński, PhD
Role: PRINCIPAL_INVESTIGATOR
1st Department of Cardiology Medical University of Warsaw
Marcin Grabowski, PhD
Role: PRINCIPAL_INVESTIGATOR
1st Department of Cardiology Medical University of Warsaw
Locations
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Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Department of Clinical Nursing, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Paweł Balsam
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Radosław Pietrzak, MD, PhD
Role: primary
Tomasz Książczyk, MD
Role: backup
References
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Balsam P, Lodzinski P, Tyminska A, Ozieranski K, Januszkiewicz L, Glowczynska R, Wesolowska K, Peller M, Pietrzak R, Ksiazczyk T, Borodzicz S, Koltowski L, Borkowski M, Werner B, Opolski G, Grabowski M. Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study. Cardiol J. 2018;25(1):52-59. doi: 10.5603/CJ.a2017.0102. Epub 2017 Aug 25.
Other Identifiers
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ECG-shirt study
Identifier Type: -
Identifier Source: org_study_id
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