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Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

A

Affiliated Hospital of Nantong University

Status

Enrolling

Conditions

Kawasaki Disease

Treatments

Diagnostic Test: Echocardiography, Genomics NGS sequencing

Study type

Observational

Funder types

Other

Identifiers

NCT05347901
LCYJ-A06

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

1 month to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

800 participants in 2 patient groups

Health Control
Description:
Health children with age and sex paired with experimental group
Treatment:
Diagnostic Test: Echocardiography, Genomics NGS sequencing
Kawasaki Disease
Description:
KD patients, with no congenital heart disease, metabolic disease or Immune deficiency disease.
Treatment:
Diagnostic Test: Echocardiography, Genomics NGS sequencing

Trial contacts and locations

4

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Central trial contact

Jianmei Zhao, PhD.

Data sourced from clinicaltrials.gov

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