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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405658 on ClinicalTrials.gov