Electrocardiography for the Automatic Analysis of Arrhythmia in Children

NCT05272722 | Unknown

• 1 other identifier: 2M6/UK1/417/2020
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmia in Children

Keywords

Arrhythmia; Children; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Development and validation of ECG automatic analysis tool

  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

Study Arms (4)

Infants (under age of 1 year old)

ECG assessment and Holter monitoring

Diagnostic Test: ECG,

1 - 5 years old children

ECG assessment and Holter monitoring

Diagnostic Test: ECG,

6 -12 years old children

ECG assessment and Holter monitoring

Diagnostic Test: ECG,

13-18 years old adolescents

ECG assessment and Holter monitoring

Diagnostic Test: ECG,

Interventions

ECG, DIAGNOSTIC_TEST

Holter monitoring

1 - 5 years old children; 13-18 years old adolescents; 6 -12 years old children; Infants (under age of 1 year old)

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• age 0-18
• signed informed consent form by parents/guardians and children (if at the age of 16 or more).
• diagnosed arrhythmia

You may not qualify if:

• age above 18 years old
• lack of consent
• coexisting conditions and/or drugs which can cause changes in the ECG recording

Sponsors & Collaborators

• Medical University of Warsaw: lead
• National Center for Research and Development, Poland: collaborator
• Cardiomatics: collaborator

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Radoslaw Pietrzak, Phd

CONTACT

+48607162707; radoslaw.pietrzak@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

PL (1)