Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

NCT ID: NCT05347901

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-07-31

Brief Summary

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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

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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.

Conditions

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Kawasaki Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Health Control

Health children with age and sex paired with experimental group

Echocardiography, Genomics NGS sequencing

Intervention Type DIAGNOSTIC_TEST

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.

Echocardiography, Genomics NGS sequencing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University Qidong Branch

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital of Nantong University

OTHER

Sponsor Role collaborator

Jiangsu Hai'an People's Hospital

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianmei Zhao, PhD.

Role: STUDY_CHAIR

Affiliated Hospital of Nantong University

Locations

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Affiliated Hospital of Nantong University

Nantong, Jangsu, China

Site Status RECRUITING

Jiangsu Hailan People's Hospital

Haian, Jiangsu, China

Site Status RECRUITING

Nantong first People's Hospital

Nantong, Jiangsu, China

Site Status RECRUITING

Children's Hospital of Fudan University Qidong Branch

Qidong, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianmei Zhao, PhD.

Role: CONTACT

051385052399

Facility Contacts

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Jianmei Zhao, PhD.

Role: primary

051385052399

Hao Fang, M.D.

Role: primary

Tao Chen, M.D.

Role: primary

Ting Xu, M.D.

Role: primary

Other Identifiers

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LCYJ-A06

Identifier Type: -

Identifier Source: org_study_id

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