Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool (AI-ECG-CHD)

Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening.

Study Overview

• Status: Recruiting
• Conditions: Artificial Intelligence; Diagnosis; Congenital Heart Disease in Children; Deep Learning; Electrocardiogram

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Sun Jing, MD; Phone Number: 15618497517; Email: sunjing02@xinhuamed.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Sun Jing, MD; Phone Number: 15618497517; Email: sunjing02@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Our dataset consisted of retrospective data from patients aged under 18 years who had complete ECG, echocardiography, examination and medical history information.

Description

Inclusion Criteria:

• The age of first visit was from 3 months after birth to 18 years old;
• In the atrial septal defect group, patients in the case group were required to complete ECG examination and confirmed by careful cardiac ultrasonography that there was a simple secondary atrial septal defect without other complex heart malformations (such as ectopic pulmonary vein drainage, trunk conus artery malformation, interrupted aortic arch, primary pulmonary hypertension, etc.). In the pulmonary hypertension group, the presence of CHD associated pulmonary hypertension was confirmed by careful cardiac ultrasonography examination. The control group was the patients with normal intracardiac structure examined by cardiac ultrasonography. The time interval between ECG examination and echocardiography examination of all patients was < 1 month;
• No major illness at the time of initial visit (non-life-threatening organic disease caused by congenital heart disease).

Exclusion Criteria:

• Age of first visit < 3 months or > 18 years old;
• Complicated congenital heart disease (such as anomalous pulmonary venous drainage, trunk conus artery malformation, interrupted aortic arch, primary pulmonary hypertension, etc.);
• The clinical information is incomplete, including the lack of ECG or echocardiography information, or the time interval between ECG and echocardiography is > 1 month;
• Life-threatening diseases associated with other organ systems;

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control
Pulmonary hypertension
Atrial septal defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Large-scale ECG database for children	The ECG data of children from multiple centers were collected and collated, including common and rare CHD types and normal children's ECG, to construct a large-scale ECG database covering different ages and CHD diseases. In addition, the original ECG data (digital signals or ECG images) will be pre-processed to make it conform to the input standards of deep learning models, so as to improve the quality and efficiency of subsequent model training and reduce the heterogeneity of multi-center ECG data.	2024.01.01-2024.12.30
Artificial intelligence-assisted electrocardiogram model for CHD in Children	The deep neural network model will be established based on algorithms such as convolutional neural network, transformers and Autoencoders, and will be trained and verified in the multi-center children's ECG dataset (85%) established based on CCHDnet, so as to continuously optimize the model and improve the diagnostic performance of the model. Further, the deep learning model based on the single disease of CHD will be integrated, and the CHD-ECG AI system will be built, and the model will eventually automatically extract and recognize the general basic information such as the age and gender of the child through the ECG, and then predict and classify the potential CHD characteristics in the ECG based on this. The research group initially selected the representative subtypes of CHD - atrial septal defect and pulmonary hypertension as the initial direction of exploration.	2024.01.01-2025.12.30

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: XHEC-C-2024-053-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No