Clinical Precise Diagnosis and Treatment in the Kawasaki Disease
- Conditions
- Kawasaki Disease
- Interventions
- Diagnostic Test: Echocardiography, Genomics NGS sequencing
- Registration Number
- NCT05347901
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Brief Summary
The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki disease, etc.
- Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will acquire blood samples with complete clinical data and prognostic information. Using clinicopathology, molecular biology, gene diagnostics and other techniques to verify the expression differences of target genes and proteins and analyze their expression levels; To analyze the role of target genes and proteins in the occurrence and development of Kawasaki disease and their correlation with the risk of coronary artery injury. In vitro and in vivo KD (Kawasaki Disease) model was used to investigate the role of target genes in Kawasaki disease by gene interference and various molecular biological techniques.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Individual patient's medical file data confirmed the diagnosis of KD using diagnostic criteria issued by the American Heart Association in 2017;
- Patients were respond to IVIG treatment;
- the patients aged from 2 months to 14 years old;
- All included patients required to sign an informed consent form.
- The patients with severe infections;
- The patients with a history of tuberculosis or recent close contact with tuberculosis;
- The patient vaccinated with live vaccine in 6 months;
- The patients with the application of hormone or other immunosuppressive agents;
- The patients didn"t want to signed informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Health Control Echocardiography, Genomics NGS sequencing Health children with age and sex paired with experimental group Kawasaki Disease Echocardiography, Genomics NGS sequencing KD patients, with no congenital heart disease, metabolic disease or Immune deficiency disease.
- Primary Outcome Measures
Name Time Method Z-score of coronary artery 4 weeks Calculate z-score by using LMS regression form echocardiography data
Differential gene profile 1 week after IVIG treatment Differential expression analysis of NGS sequencing in genomics
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Jiangsu Hailan People's Hospital
🇨🇳Haian, Jiangsu, China
Children's Hospital of Fudan University Qidong Branch
🇨🇳Qidong, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jangsu, China
Nantong first People's Hospital
🇨🇳Nantong, Jiangsu, China