Clinical trial NCT05347901: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kawasaki Disease
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Fudan University Qidong Branch
name: Second Affiliated Hospital of Nantong University
name: Jiangsu Hai'an People's Hospital
First posted: 2022-04-26
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children under the care of consultant in hospital for 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.

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.

Primary outcomes:
measure: Z-score of coronary artery
timeFrame: 2 weeks
measure: Z-score of coronary artery
timeFrame: 4 weeks
measure: Differential gene profile
timeFrame: 0 week
measure: Differential gene profile
timeFrame: 1 week after IVIG treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jangsu
city: Haian
country: China
facility: Jiangsu Hailan People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong first People's Hospital
state: Jiangsu
city: Qidong
country: China
facility: Children's Hospital of Fudan University Qidong Branch
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Jianmei Zhao, PhD.
role: STUDY_CHAIR
References: