- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272722
Electrocardiography for the Automatic Analysis of Arrhythmia in Children
Electrocardiographic Signal Assessment for the Development of the Electrocardiogram Automatic Analysis in Children Suffering From Heart Rhythm Disturbances
Study Overview
Detailed Description
The study is an investigator-initiated, single centre, prospective observational trial. The study will be carried out in in the department of pediatric cardiology of Medical University of Warsaw.
Aim of the study: To develop an innovative tool for automatic analysis of cardiac arrhythmias and conduction for pediatric patients The study group will consist of 275 children with various heart rytm disturbances including those with congenital heart diseases following open heart surgery. The study group will be divided into the the age categories as follows: 50 infants under the age of 1 year old, 75 children 1-5 years old, 75 children aged 6-12 years and 75 aged 13-18 years.
Control group will consist of 400 healthy volunteers (100 in each age group defined as in the study group).
All patients will undergo
- 12-lead ECG recording
- 24-hour ECG Holter monitoring
Together with the ECG signals patients medical history will be acquired including:
- identification number
- exact date and time of ECG obtaining
- age
- height
- weight
- diagnosed comorbidities - especially informations regarding the diagnosed congenital heart disease (if applicable).
After obtaining the ECG signals they will be analyzed by an experienced pediatric cardiologist. The obtained signals together with the clinical interpretation will be transferred to Cardiomatics and used to build algorithms that will enable high-quality automatic analysis in children. The algorithms will be built using deep neural network architectures, such as ResNet, and will operate on filtered ECG signals. The created unique database of different arrhythmias in pediatric patients will be used to "train" the algorithm. Once the algorithm is developed its reliability will be tested using signals from a created data base that were not used to "train" the algorithm in the earlier stage of the process.
The creation of a reliable system for automatic analysis of ECG recordings using the Holter method in children will not only improve the work of clinicians but also increase the availability and universality of this test, which is of great importance in the detection of rhythm and conduction disorders in pediatrics. Technology will also improve the recognition of broad range of diseases, so it make possible to undertake adequate therapy at an earlier stage.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Radoslaw Pietrzak, PhD
- Phone Number: +48607162707
- Email: radoslaw.pietrzak@wum.edu.pl
Study Locations
-
-
Mazowieckie
-
Warsaw, Mazowieckie, Poland, 02-091
- Recruiting
- Medical University of Warsaw
-
Contact:
- Radoslaw Pietrzak, PhD
- Phone Number: +48607162707
- Email: radoslaw.pietrzak@wum.edu.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
275 children with various heart rytm disturbances including those with congenital heart diseases following open heart surgery. he study group will be divided into the the age categories as follows: 50 infants under the age of 1 year old, 75 children 1-5 years old, 75 children aged 6-12 years and 75 aged 13-18 years.
Control group will consist of 400 healthy volunteers (100 in each age group defined as in study group).
Description
Inclusion Criteria:
- age 0-18
- signed informed consent form by parents/guardians and children (if at the age of 16 or more).
- diagnosed arrhythmia
Exclusion Criteria:
- age above 18 years old
- lack of consent
- coexisting conditions and/or drugs which can cause changes in the ECG recording
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infants (under age of 1 year old)
ECG assessment and Holter monitoring
|
Holter monitoring
|
1 - 5 years old children
ECG assessment and Holter monitoring
|
Holter monitoring
|
6 -12 years old children
ECG assessment and Holter monitoring
|
Holter monitoring
|
13-18 years old adolescents
ECG assessment and Holter monitoring
|
Holter monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development and validation of ECG automatic analysis tool
Time Frame: 01/04/2021-01/04/2023
|
Development and validation of new tool for automatic assessment, analysis, and interpretation of electrocardiographic signals (ECG) in pediatric patients
|
01/04/2021-01/04/2023
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2M6/UK1/417/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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