Clinical Study on an Artificial Intelligence-Assisted Chest Radiograph Model Based on Big Data and Deep Learning for Early Detection of Kawasaki Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Case group

The age of seeking medical treatment is less than or equal to 18 years old; ·The medical record system diagnosis contains the diagnosis of "Kawasaki Disease", "mucocutaneous lymph node syndrome" or "IVIG non-response Kawasaki disease"

At least one complete chest X-ray examination data (images and reports) is available during the same hospitalization

Control group

Disqualifiers

Case group

Chest X-ray quality issues: Severe artifacts, overexposure/underexposure leading to inability to assess key structures

Incomplete clinical information, including lack of chest X-ray examination, laboratory tests, and unclear days of fever Inability to determine the final diagnosis (such as loss to follow-up, diagnosis in doubt)

Control group

Trial population

The case group consists of children diagnosed with Kawasaki Disease (KD) over the past 10 years. The inclusion criteria include: Children diagnosed with Kawasaki Disease based on clinical symptoms and confirmed by medical records. The control group consists of data from patients with fever lasting ≥3 days, matched to the KD cohort based on diagnosis year, month, and clinical characteristics. The study focuses on examining the relationship between chest X-ray features and Kawasaki Disease in these patients.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • AI-Based Early Warning System for Kawasaki Disease

    Diagnostic test

    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.

Treatment groups

20,000 Participants
are divided into 2 treatment groups
Group A: Case group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Area Under Curve

Time frame
Up to 14 days after fever onset
2

sensitivity

Time frame
Up to 14 days after fever onset
3

specificity

Time frame
Up to 14 days after fever onset

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Children's Hospital of Soochow University

Collaborator

Hunan Provincial People's Hospital

Collaborator

Women and Children Hospital of Qinghai Province

Collaborator

Yangzhou No.1 People's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: