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Biomedical Shirt-based ECG Monitoring (ECG-shirt)

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ClinicalTrials.gov Identifier: NCT03068169
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Marcin Grabowski, Medical University of Warsaw

Brief Summary:
Cardiovascular diseases (CVD) are associated with high healthcare costs, as well as are a leading cause of mortality and hospitalizations. The main challenge for today's researchers is to develop new technologies, which may help to improve diagnosis of CVD, thereby reducing healthcare costs and quality of patients' lives. Non-invasive wearable electronics offer new capabilities for the diagnosis and management of patients with CVD. Several reports with wearable electronics have been published, in which achieved very positive results with high accuracy. Aim of our study is to show utility of biomedical shirt-based ECG monitoring of patients with CVD in different clinical situations using Nuubo® ECG (nECG) system.

Condition or disease
ECG Monitoring

Detailed Description:

The study is an investigator-initiated, multicentre, prospective observational trial. The study will be carried out in 2 tertiary university hospitals on cardiology wards (adult and pediatric). The study will consist of four independent groups of patients whose ECG will be monitored using the biomedical shirt. The study groups will be as follows: patients after pulmonary veins isolation (PVI), cardiac resynchronization therapy (CRT) recipients, patients during cardiac rehabilitation after myocardial infarction, and pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study (EPS). Approval for all study groups was obtained from institutional review board.

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.


Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomedical Shirt-based ECG Monitoring in Relevant Clinical Situations
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 31, 2018



Primary Outcome Measures :
  1. Association between early recurrences of atrial tachyarrhythmias (ERAT) during blanking period on long-term effectiveness of pulmonary veins isolation (PVI) using nECG shirt. [ Time Frame: 13 months ]
    Assessment of the rationale for the use of blanking period and to determine whether the early recurrences of atrial tachyarrhythmias (ERAT) burden influences on long-term effectiveness of pulmonary veins isolation (PVI) using nECG shirt. The study might demonstrate which patients with ERAT remain at risk of long-term recurrence of atrial fibrillation (AF).

  2. Assessment of the usefulness of nECG shirt in detection of fusion and pseudo-fusion beats in cardiac resynchronization therapy (CRT) recipients. [ Time Frame: 7 months ]
  3. Assessment of the impact of the use of a pedometer combined with nECG shirt on the level of daily physical activity and its intensity. [ Time Frame: 12 month ]
  4. Creation of an algorithm based on nECG monitoring using wearable shirt to differentiate atrioventricular reentry tachycardia (AVRT) with atrioventricular nodal reentry tachycardia (AVNRT) in pediatric patients suffering from supraventricular tachycardia. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Assessment of the influence of CRT implantation on amount of physical activity measured by nECG shirt. [ Time Frame: 7 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will be consisted of four independent patient groups: 30 patients with paroxysmal AF treated with PVI; 30 patients scheduled for CRT implantation; 120 patients after early post-infarction ambulatory cardiac rehabilitation; 40 patients, between 5 to 18 years old, with diagnosed SVT and who are qualified for electrophysiological study (EPS).
Criteria

Patients after PVI

Inclusion Criteria:

  • PVI in a patient with paroxysmal AF
  • 18 - 70 years old
  • Signed written informed consent Exclusion criteria
  • BMI ≥35 kg/m2
  • 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

Inclusion criteria:

  • > 18 years old
  • Meeting the current European Society of Cardiology Guidelines indications for CRT implantation (including upgrades)
  • Signed written informed consent Exclusion criteria
  • 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

Inclusion criteria:

  • Patients within 3 months after myocardial infarction, after completed early post-infarction ambulatory cardiac rehabilitation
  • Signed written informed consent
  • 18 - 80 years old

Exclusion criteria:

  • 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

Inclusion criteria:

  • 5-18 years old
  • Patients with diagnosed SVT qualified to EPS
  • Signed written informed consent

Exclusion criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068169


Contacts
Contact: Paweł Balsam, PhD 605152120 ext 0048 pawel.balsam@me.com
Contact: Piotr Lodziński, PhD 601813004 ext 0048 piotr.lodzinski@me.com

Locations
Poland
Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw Recruiting
Warsaw, Mazowieckie, Poland, 02-091
Contact: Radosław Pietrzak, MD, PhD    607162707      
Contact: Tomasz Książczyk, MD    501148914      
Principal Investigator: Radosław Pietrzak, MD, PhD         
Sub-Investigator: Tomasz Książczyk, MD, PhD         
Sub-Investigator: Piotr Lodziński, MD, PhD         
Sub-Investigator: Paweł Balsam, MD, PhD         
Sub-Investigator: Sonia Borodzicz, student         
Sub-Investigator: Justyna Dembowska, student         
Sub-Investigator: Bożena Werner, MD, Prof         
Department of Clinical Nursing, Medical University of Warsaw Not yet recruiting
Warsaw, Mazowieckie, Poland, 02-097
Contact: Renata Główczyńska, MD, PhD    502773436 ext 0048    reniarenata@gmail.com   
Contact: Katarzyna Wesołowska, PT, PhD       wesolowska_katarzyna@wp.pl   
Principal Investigator: Renata Główczyńska, MD, PhD         
Sub-Investigator: Katarzyna Wesołowska, PT, PhD         
Sub-Investigator: Grzegorz Opolski, MD, Prof         
Paweł Balsam Not yet recruiting
Warsaw, Mazowieckie, Poland, 02-097
Contact: Paweł Balsam, MD, PhD    605152120    pawel.balsam@me.com   
Contact: Piotr Lodziński, MD, PhD    601813004    piotr.lodzinski@me.com   
Principal Investigator: Paweł Balsam, MD, PhD         
Principal Investigator: Piotr Lodziński, MD, PhD         
Principal Investigator: Marcin Grabowski, MD, PhD         
Principal Investigator: Renata Główczyńska, MD, PhD         
Sub-Investigator: Agata Tymińska, MD         
Sub-Investigator: Krzysztof Ozierański, MD         
Sub-Investigator: Łukasz Januszkiewicz, MD         
Sub-Investigator: Michał Peller, MD         
Sub-Investigator: Grzegorz Opolski, MD, Prof         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Renata Główczyńska, PhD 1st Department of Cardiology Medical University of Warsaw
Principal Investigator: Paweł Balsam, PhD 1st Department of Cardiology Medical University of Warsaw
Principal Investigator: Piotr Lodziński, PhD 1st Department of Cardiology Medical University of Warsaw
Principal Investigator: Marcin Grabowski, PhD 1st Department of Cardiology Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcin Grabowski, Clinical Professor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03068169     History of Changes
Other Study ID Numbers: ECG-shirt study
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available for meta-analysis

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcin Grabowski, Medical University of Warsaw:
remote ECG
atrial fibrillation
cardiac rehabilitation
cardiac resynchronization therapy
supraventricular tachycardia