Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02317913
Other study ID # kd2008-2012
Secondary ID
Status Completed
Phase N/A
First received December 8, 2014
Last updated March 8, 2016
Start date April 2013
Est. completion date January 2016

Study information

Verified date March 2015
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .


Description:

A questionnaire form and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. All patients with KD diagnosed during January 2008 through December 2012 will be recruited and analyzed. Distribution of age at onset and seasonal features of disease incidence wil be described. Univariate and multivariate association analyses will be performed to identify risk factors to Coronary arterial lesions (CAL) defined as ectasia or aneurysm by using multivariate logistic regression model.


Recruitment information / eligibility

Status Completed
Enrollment 2402
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- The 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002, was adopted. Cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography:

1. fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy)

2. bilateral conjunctival congestion

3. changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa

4. polymorphous exanthema

5. changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage

6. acute nonpurulent cervical lymphadenopathy. In addition, the cases of incomplete KD, diagnosed with referring to the guidelines for incomplete KD made by American Academy of Pediatrics (AAP) and American Heart Association (AHA) in 2004, were also included in this investigation

Exclusion Criteria:

- The cases were not in accordance with the recruited criteria

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Children Hospital of Fudan University Shanghai Shanghai

Sponsors (9)

Lead Sponsor Collaborator
Children's Hospital of Fudan University Changhai Hospital, Children's Hospital of Shanghai Jiao Tong University, Ruijin Hospital, Shanghai Children's Medical Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Sixth People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of coronary artery lesions(CAL) according to the result of the echocardiography performed in the acute phase ,early and late recovery of Kawasaki disease 5 years No
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 NCT00841789 - A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease Phase 2
Completed NCT00760435 - Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease Phase 3
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