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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05347901
Enrollment
800
Registered
2022-04-26
Start date
2021-08-01
Completion date
2024-07-31
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DIAGNOSTIC_TESTEchocardiography, 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

Sponsors

Children's Hospital of Fudan University Qidong Branch
CollaboratorUNKNOWN
Second Affiliated Hospital of Nantong University
CollaboratorOTHER
Jiangsu Hai'an People's Hospital
CollaboratorUNKNOWN
Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 14 Years
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 didnt want to signed informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Z-score of coronary artery2 weeksCalculate z-score by using LMS regression form echocardiography data
Differential gene profile0 weekDifferential expression analysis of NGS sequencing in genomics

Countries

China

Contacts

Primary ContactJianmei Zhao, PhD.
zjmheart@163.com051385052399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026