Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

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Brief Title

Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

Official Title

Clinical Precise Diagnosis and Treatment of Personalized Z-score Evaluation Combined With Genomic Analysis in the Repair of Coronary Artery Injury in Kawasaki Disease

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.
    


Study Type

Observational


Primary Outcome

Z-score of coronary artery


Condition

Kawasaki Disease

Intervention

Echocardiography, Genomics NGS sequencing

Study Arms / Comparison Groups

 Health Control
Description:  Health children with age and sex paired with experimental group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

800

Start Date

August 1, 2021

Completion Date

July 31, 2024

Primary Completion Date

January 31, 2024

Eligibility Criteria

        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.
      

Gender

All

Ages

1 Month - 14 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jianmei Zhao, PhD., 051385052399, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05347901

Organization ID

LCYJ-A06


Responsible Party

Sponsor

Study Sponsor

Affiliated Hospital of Nantong University

Collaborators

 Children's Hospital of Fudan University Qidong Branch

Study Sponsor

Jianmei Zhao, PhD., Study Chair, Affiliated Hospital of Nantong University


Verification Date

January 2022