Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

Kawasaki Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347901
• Other study ID #: LCYJ-A06
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Jianmei Zhao, PhD.
• Phone: 051385052399
• Email: zjmheart[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Hailan People's Hospital	Haian	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jangsu
China	Nantong first People's Hospital	Nantong	Jiangsu
China	Children's Hospital of Fudan University Qidong Branch	Qidong	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University	Children's Hospital of Fudan University Qidong Branch, Jiangsu Hai'an People's Hospital, Second Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

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