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Electrocardiography for the Automatic Analysis of Arrhythmia in Children

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ClinicalTrials.gov Identifier: NCT05272722
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : March 14, 2022
Sponsor:
Collaborators:
National Center for Research and Development, Poland
Cardiomatics
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
The project is a direct response to the identified lack of ECG diagnostic solutions dedicated to children. There are several tools for automatic ECG signal analysis in adults, but these cannot be used in the diagnosis of heart disorders among children. A digital ECG analysis technology developer, Cardiomatics, and the Medical University of Warsaw team have taken the challenge of developing an internationally innovative tool for automatic assessment, analysis, and interpretation of electrocardiographic signals in pediatric patients. The developed tool will allow cardiac arrhythmias in children to be assessed more effectively and minimize the time needed for cardiologists to evaluate data received from the Holter monitor due to the use of algorithms, which are based on artificial intelligence.

Condition or disease Intervention/treatment
Arrhythmia in Children Diagnostic Test: ECG,

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.

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Study Type : Observational
Estimated Enrollment : 675 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrocardiographic Signal Assessment for the Development of the Electrocardiogram Automatic Analysis in Children Suffering From Heart Rhythm Disturbances
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
Infants (under age of 1 year old)
ECG assessment and Holter monitoring
Diagnostic Test: ECG,
Holter monitoring

1 - 5 years old children
ECG assessment and Holter monitoring
Diagnostic Test: ECG,
Holter monitoring

6 -12 years old children
ECG assessment and Holter monitoring
Diagnostic Test: ECG,
Holter monitoring

13-18 years old adolescents
ECG assessment and Holter monitoring
Diagnostic Test: ECG,
Holter monitoring




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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).

Criteria

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

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): NCT05272722


Contacts
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Contact: Radoslaw Pietrzak, Phd +48607162707 radoslaw.pietrzak@wum.edu.pl

Locations
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Poland
Medical University of Warsaw Recruiting
Warsaw, Mazowieckie, Poland, 02-091
Contact: Radoslaw Pietrzak, PhD    +48607162707    radoslaw.pietrzak@wum.edu.pl   
Sponsors and Collaborators
Medical University of Warsaw
National Center for Research and Development, Poland
Cardiomatics
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT05272722    
Other Study ID Numbers: 2M6/UK1/417/2020
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Warsaw:
Arrhythmia
Children
Artificial intelligence
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes