Clinical Study on an Artificial Intelligence-Assisted Chest Radiograph Model Based on Big Data and Deep Learning for Early Detection of Kawasaki Disease
NCT07405658 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000
Last updated 2026-02-12
Summary
The goal of this observational study is to develop an AI-based early warning system for Kawasaki Disease (KD) using chest X-rays (CXR) in children diagnosed with Kawasaki Disease. The main question\[s\] it aims to answer are:
1. Can AI modeling of CXR features help identify high-risk KD patients earlier than current diagnostic methods?
2. Can the AI system predict the optimal IVIG treatment window and coronary artery risks in KD patients?
Participants will:
Provide retrospective data on chest X-rays and clinical data (CRP, coronary ultrasound, etc.) Allow analysis of CXR features using deep learning models to extract relevant patterns Have their data incorporated into a federated learning model to ensure privacy and data security
Conditions
- Kawasaki Disease
- Chest X-ray for Clinical Evaluation
- Mucocutaneous Lymph Node Syndrome
Interventions
- DIAGNOSTIC_TEST
-
AI-Based Early Warning System for Kawasaki Disease
This study utilizes an AI-based early warning system for Kawasaki Disease (KD) to predict the optimal IVIG treatment window and assess coronary risk. The system analyzes chest X-ray (CXR) images and integrates them with clinical data such as CRP levels and clinical symptoms. The intervention involves the development of a multi-modal dynamic prediction model that uses a dual-pathway convolutional neural network (CNN) to extract relevant CXR features and a graph neural network to integrate laboratory indicators. The AI system outputs a prediction of the IVIG treatment window and estimates the risk of coronary artery damage. This early warning system aims to reduce diagnosis time and improve treatment outcomes by identifying high-risk KD patients earlier, enabling timely intervention and personalized treatment plans. The model is designed to be lightweight (under 50MB) to be easily applicable in primary care settings.
Sponsors & Collaborators
-
Children's Hospital of Soochow University
collaborator OTHER -
Hunan Provincial People's Hospital
collaborator OTHER -
Women and Children Hospital of Qinghai Province
collaborator OTHER -
Yangzhou No.1 People's Hospital
collaborator OTHER -
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Kun Sun, Doctoral degree · Xinhua hospital affiliated with Shanghai Jiao Tong university school of medicine
Eligibility
- Min Age
- 0 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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