Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kawasaki Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Jianmei Zhao, PhD.; Phone Number: 051385052399; Email: zjmheart@163.com

Study Locations

• China
  • Jangsu
    • Nantong, Jangsu, China, 226000
      • Recruiting
      • Affiliated Hospital Of Nantong University
      • Contact: Jianmei Zhao, PhD.; Phone Number: 051385052399; Email: zjmheart@163.com
  • Jiangsu
    • Haian, Jiangsu, China, 226000
      • Recruiting
      • Jiangsu Hailan People's Hospital
      • Contact: Hao Fang, M.D.
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • Nantong First People's Hospital
      • Contact: Tao Chen, M.D.
    • Qidong, Jiangsu, China, 226000
      • Recruiting
      • Children's Hospital of Fudan University Qidong Branch
      • Contact: Ting Xu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Children under the care of consultant in hospital for Kawasaki disease

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Z-score of coronary artery	Calculate z-score by using LMS regression form echocardiography data	2 weeks
Z-score of coronary artery	Calculate z-score by using LMS regression form echocardiography data	4 weeks
Differential gene profile	Differential expression analysis of NGS sequencing in genomics	0 week
Differential gene profile	Differential expression analysis of NGS sequencing in genomics	1 week after IVIG treatment

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Collaborators: Second Affiliated Hospital of Nantong University; Children's Hospital of Fudan University Qidong Branch; Jiangsu Hai'an People's Hospital
• Investigators: Study Chair: Jianmei Zhao, PhD., Affiliated Hospital Of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: LCYJ-A06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No