Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05347901
Collaborator
Children's Hospital of Fudan University Qidong Branch (Other), Second Affiliated Hospital of Nantong University (Other), Jiangsu Hai'an People's Hospital (Other)
800
4
36
200
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiography, Genomics NGS sequencing

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 Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Health Control

Health children with age and sex paired with experimental group

Diagnostic Test: Echocardiography, Genomics NGS sequencing
The inner diameter of left main coronary artery, anterior descending branch, circumflex branch and right coronary artery was measured by echocardiography. Blood samples were send for genomics NGS sequencing

Kawasaki Disease

KD patients, with no congenital heart disease, metabolic disease or Immune deficiency disease.

Diagnostic Test: Echocardiography, Genomics NGS sequencing
The inner diameter of left main coronary artery, anterior descending branch, circumflex branch and right coronary artery was measured by echocardiography. Blood samples were send for genomics NGS sequencing

Outcome Measures

Primary Outcome Measures

  1. Z-score of coronary artery [2 weeks]

    Calculate z-score by using LMS regression form echocardiography data

  2. Z-score of coronary artery [4 weeks]

    Calculate z-score by using LMS regression form echocardiography data

  3. Differential gene profile [0 week]

    Differential expression analysis of NGS sequencing in genomics

  4. Differential gene profile [1 week after IVIG treatment]

    Differential expression analysis of NGS sequencing in genomics

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Nantong University Nantong Jangsu China 226000
2 Jiangsu Hailan People's Hospital Haian Jiangsu China 226000
3 Nantong first People's Hospital Nantong Jiangsu China 226000
4 Children's Hospital of Fudan University Qidong Branch Qidong Jiangsu China 226000

Sponsors and Collaborators

  • Affiliated Hospital of Nantong University
  • Children's Hospital of Fudan University Qidong Branch
  • Second Affiliated Hospital of Nantong University
  • Jiangsu Hai'an People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Affiliated Hospital of Nantong University
ClinicalTrials.gov Identifier:
NCT05347901
Other Study ID Numbers:
  • LCYJ-A06
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022