Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05347901
Other study ID # LCYJ-A06
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05911386 - Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
Recruiting NCT02951234 - A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease N/A
Active, not recruiting NCT02853266 - Measurement of Antibodies in Adults With a History of Kawasaki Disease N/A
Active, not recruiting NCT04747847 - Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease Early Phase 1
Withdrawn NCT04535518 - Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease Phase 3
Recruiting NCT01917721 - Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease Phase 2
Recruiting NCT04656184 - A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment Phase 3
Recruiting NCT03200561 - A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study) Phase 3
Completed NCT01440075 - Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease N/A
Completed NCT02179853 - Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease Phase 1/Phase 2
Withdrawn NCT02980263 - Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease Phase 2
Enrolling by invitation NCT02359643 - Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease N/A
Recruiting NCT04278404 - Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Completed NCT00760435 - Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease Phase 3
Completed NCT00841789 - A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease Phase 2
Not yet recruiting NCT05643651 - Rivaroxaban for Children With Giant Coronary Artery Aneurysms After Kawasaki Disease Phase 4
Recruiting NCT02114099 - Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease Phase 2
Not yet recruiting NCT05091229 - A Blood Test to Diagnose Kawasaki Disease
Completed NCT01431105 - Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities Phase 1/Phase 2
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford