Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool
Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Apr 22, 2024
Trial Information
Current as of July 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new tool that uses artificial intelligence (AI) to help detect congenital heart disease (CHD) in children by analyzing their electrocardiograms (ECGs), which are simple tests that record the electrical activity of the heart. CHD is the most common heart condition present at birth, and finding it early can lead to better treatment and outcomes for children. The goal of the trial is to improve how we screen for CHD using advanced AI technology, which can analyze ECGs more effectively than traditional methods.
Children aged between 3 months and 18 years who have specific heart conditions, like certain types of atrial septal defects or related pulmonary hypertension, may be eligible to participate. To take part, they must have had an ECG and a detailed heart ultrasound (echocardiogram) that confirms their condition within a month of each other. Participants can expect to have their ECGs analyzed by this new AI system, which aims to make the process of identifying heart issues faster and more accurate. This trial is currently recruiting participants, and it seeks to gather valuable information that could enhance how we diagnose CHD in the future.
Gender
ALL
Eligibility criteria
- 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;
About Xinhua Hospital, Shanghai Jiao Tong University School Of Medicine
Xinhua Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a prominent clinical research institution renowned for its commitment to advancing medical science and patient care. Located in Shanghai, China, the hospital integrates clinical practice, education, and research, fostering innovation in various medical fields. With state-of-the-art facilities and a multidisciplinary team of experts, Xinhua Hospital conducts rigorous clinical trials aimed at evaluating new therapies and improving treatment outcomes. Its dedication to ethical standards and patient safety positions it as a leader in the global clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported