Clinical Precise Diagnosis and Treatment in the Kawasaki Disease
1 other identifier
observational
800
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedAugust 1, 2023
April 1, 2023
2.5 years
March 23, 2022
July 28, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Health Control
Health children with age and sex paired with experimental group
Kawasaki Disease
KD patients, with no congenital heart disease, metabolic disease or Immune deficiency disease.
Interventions
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
Eligibility Criteria
Children under the care of consultant in hospital for Kawasaki disease
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Affiliated Hospital of Nantong University
Nantong, Jangsu, 226000, China
Jiangsu Hailan People's Hospital
Haian, Jiangsu, 226000, China
Nantong first People's Hospital
Nantong, Jiangsu, 226000, China
Children's Hospital of Fudan University Qidong Branch
Qidong, Jiangsu, 226000, China
Biospecimen
Peripheral blood mononuclear cells
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianmei Zhao, PhD.
Affiliated Hospital of Nantong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 26, 2022
Study Start
August 1, 2021
Primary Completion
January 31, 2024
Study Completion
July 31, 2024
Last Updated
August 1, 2023
Record last verified: 2023-04