ECG MonitoringECG-shirtNCT03068169
Biomedical Shirt-based ECG Monitoring
An observational study of ECG Monitoring, run by Medical University of Warsaw at 3 sites in Poland.
Trial 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'… Read more about this study
- Who is it for?
- Ages 5 to 100 years
- Conditions the study is for
- ECG Monitoring
- How many people
- 220 participants
- Where
- 3 sitesPoland
- Study dates
- 15 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Show all 24Show fewer
- 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)
- 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
- 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
Who cannot join
- 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%.
Show all 22Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Poland3 sites, 3 recruiting
- Recruiting
Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Radosław Pietrzak, MD, PhD, 607162707
Tomasz Książczyk, MD, 501148914
- Not yet recruiting
Department of Clinical Nursing, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Renata Główczyńska, MD, PhD, 502773436 ext. 0048, reniarenata@gmail.com
Katarzyna Wesołowska, PT, PhD, wesolowska_katarzyna@wp.pl
- Not yet recruiting
Paweł Balsam
Warsaw, Masovian Voivodeship, 02-097
Paweł Balsam, MD, PhD, 605152120, pawel.balsam@me.com
Piotr Lodziński, MD, PhD, 601813004, piotr.lodzinski@me.com
About this study
Official title: Biomedical Shirt-based ECG Monitoring in Relevant Clinical Situations
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.
Read the 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.
- Conditions
- ECG Monitoring
- Keywords
- remote ECG, atrial fibrillation, cardiac rehabilitation, cardiac resynchronization therapy, supraventricular tachycardia
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Supraventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 13 months
Assessment of the usefulness of nECG shirt in detection of fusion and pseudo-fusion beats in cardiac resynchronization therapy (CRT) recipients.
Measured: 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.
Measured: 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.
Measured: 1 month
Secondary outcomes (1)
Assessment of the influence of CRT implantation on amount of physical activity measured by nECG shirt.
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start15 Jun 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ECG MonitoringStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Grabowski, Medical University of Warsaw
- Investigators
- Renata Główczyńska, PhD, Principal investigator, 1st Department of Cardiology Medical University of WarsawPaweł Balsam, PhD, Principal investigator, 1st Department of Cardiology Medical University of WarsawPiotr Lodziński, PhD, Principal investigator, 1st Department of Cardiology Medical University of WarsawMarcin Grabowski, PhD, Principal investigator, 1st Department of Cardiology Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068169
- Sponsor's protocol ID
- ECG-shirt study
- Acronym
- ECG-shirt
- Status last verified
- Jun 2017
- First submitted
- 10 Feb 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for meta-analysis
Publications
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.
PubMed 28840587
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomedical Shirt-based ECG Monitoring in Relevant Clinical Situations
- ClinicalTrials.gov ID
- NCT03068169
- Acronym / sponsor ID
- ECG-shirt / ECG-shirt study
- Conditions
- ECG Monitoring
- Keywords
- remote ECG, atrial fibrillation, cardiac rehabilitation, cardiac resynchronization therapy, supraventricular tachycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (24 listed)
- 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,
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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
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
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
1 secondary outcome
Assessment of the influence of CRT implantation on amount of physical activity measured by nECG shirt.
Time frame: 7 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Derived from this study: PubMed 28840587Balsam 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.
- Individual participant dataSharing planned: Yes. Data will be available for meta-analysis
Related trials for ECG Monitoring
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingObservational study
Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable
Monitoring, ECG
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Główczyńska, PhD principal investigator
1st Department of Cardiology Medical University of Warsaw
Paweł Balsam, PhD principal investigator
1st Department of Cardiology Medical University of Warsaw
Piotr Lodziński, PhD principal investigator
1st Department of Cardiology Medical University of Warsaw
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ECG Monitoring, run by Medical University of Warsaw at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paweł Balsam, PhD (605152120 ext. 0048, pawel.balsam@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.