Electrocardiographic Signal Assessment for the Development of the Electrocardiogram Automatic Analysis in Children Suffering From Heart Rhythm Disturbances
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 675
- 试验地点
- 1
- 主要终点
- Development and validation of ECG automatic analysis tool
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent form by parents/guardians and children (if at the age of 16 or more).
- •diagnosed arrhythmia
排除标准
- •age above 18 years old
- •lack of consent
- •coexisting conditions and/or drugs which can cause changes in the ECG recording
结局指标
主要结局
Development and validation of ECG automatic analysis tool
时间窗: 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
次要结局
未报告次要终点