Arrhythmia in ChildrenNCT05272722
Electrocardiography for the Automatic Analysis of Arrhythmia in Children
An observational study of Arrhythmia in Children, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Arrhythmia in Children
- What is being tested?
- ECG,
- How many people
- 675 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2021to 1 Apr 2023
- 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 1 day to 18 years
- All sexes
- Child, Adult
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).
Who may be able to join
- age 0-18
- signed informed consent form by parents/guardians and children (if at the age of 16 or more).
- diagnosed arrhythmia
Who cannot join
- age above 18 years old
- lack of consent
- coexisting conditions and/or drugs which can cause changes in the ECG recording
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Radoslaw Pietrzak, PhD, +48607162707, radoslaw.pietrzak@wum.edu.pl
About this study
Official title: Electrocardiographic Signal Assessment for the Development of the Electrocardiogram Automatic Analysis in Children Suffering From Heart Rhythm Disturbances
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.
Read the 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.
- Conditions
- Arrhythmia in Children
- Being tested
- ECG,
- Keywords
- Arrhythmia, Children, Artificial intelligence
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG,Diagnostic test
Holter monitoring
| Study group | Role | What they receive |
|---|---|---|
| Infants (under age of 1 year old) | ECG assessment and Holter monitoring Receives: Diagnostic Test: ECG, | |
| 1 - 5 years old children | ECG assessment and Holter monitoring Receives: Diagnostic Test: ECG, | |
| 6 -12 years old children | ECG assessment and Holter monitoring Receives: Diagnostic Test: ECG, | |
| 13-18 years old adolescents | ECG assessment and Holter monitoring Receives: Diagnostic Test: ECG, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 01/04/2021-01/04/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Apr 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmia in ChildrenStudies 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
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research and Development, Poland, Cardiomatics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272722
- Sponsor's protocol ID
- 2M6/UK1/417/2020
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic Signal Assessment for the Development of the Electrocardiogram Automatic Analysis in Children Suffering From Heart Rhythm Disturbances
- ClinicalTrials.gov ID
- NCT05272722
- Acronym / sponsor ID
- 2M6/UK1/417/2020
- Conditions
- Arrhythmia in Children
- Keywords
- Arrhythmia, Children, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- National Center for Research and Development, Poland, Cardiomatics
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 9 Mar 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infants (under age of 1 year old) | – | Diagnostic Test: ECG,ECG assessment and Holter monitoring |
| 1 - 5 years old children | – | Diagnostic Test: ECG,ECG assessment and Holter monitoring |
| 6 -12 years old children | – | Diagnostic Test: ECG,ECG assessment and Holter monitoring |
| 13-18 years old adolescents | – | Diagnostic Test: ECG,ECG assessment and Holter monitoring |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (3 listed)
- age 0-18
- signed informed consent form by parents/guardians and children (if at the age of 16 or more).
- diagnosed arrhythmia
Key exclusion criteria (3 listed)
- age above 18 years old
- lack of consent
- coexisting conditions and/or drugs which can cause changes in the ECG recording
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG,Holter monitoring | Diagnostic test | 1 - 5 years old children, 13-18 years old adolescents, 6 -12 years old children, Infants (under age of 1 year old) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia in Children, run by Medical University of Warsaw at 1 site 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 3 inclusion and 3 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Radoslaw Pietrzak, Phd (+48607162707, radoslaw.pietrzak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and validation of ECG automatic analysis tool (time frame: 01/04/2021-01/04/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2022.