Biomedical Shirt-based ECG Monitoring

NCT03068169 | Unknown

• 1 other identifier: ECG-shirt study
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

ECG Monitoring

Keywords

remote ECG; atrial fibrillation; cardiac rehabilitation; cardiac resynchronization therapy; supraventricular tachycardia

Outcome Measures

Primary Outcomes (4)

• Association between early recurrences of atrial tachyarrhythmias (ERAT) during blanking period on long-term effectiveness of pulmonary veins isolation (PVI) using nECG shirt.

  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).

  13 months

• Assessment of the usefulness of nECG shirt in detection of fusion and pseudo-fusion beats in cardiac resynchronization therapy (CRT) recipients.

  7 months

• Assessment of the impact of the use of a pedometer combined with nECG shirt on the level of daily physical activity and its intensity.

  12 month

• 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.

  1 month

Secondary Outcomes (1)

• Assessment of the influence of CRT implantation on amount of physical activity measured by nECG shirt.

  7 month

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• PVI in a patient with paroxysmal AF
• years old

You may not qualify if:

• 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
• \> 18 years old
• Meeting the current European Society of Cardiology Guidelines indications for CRT implantation (including upgrades)
• 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
• Patients within 3 months after myocardial infarction, after completed early post-infarction ambulatory cardiac rehabilitation

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (3)

Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

Department of Clinical Nursing, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

NOT YET RECRUITING

Paweł Balsam

Warsaw, Masovian Voivodeship, 02-097, Poland

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 28840587 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł Balsam, PhD

CONTACT

605152120; pawel.balsam@me.com

Piotr Lodziński, PhD

CONTACT

601813004; piotr.lodzinski@me.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 1, 2017
• Study Start: June 15, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 31, 2018
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

PL (3)