Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Completed

• Conditions: Kawasaki Disease

• Registration Number: NCT02317913
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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 .

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-17
• Status Verified: 2015-03
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2402

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of coronary artery lesions(CAL)	5 years	according to the result of the echocardiography performed in the acute phase ,early and late recovery of Kawasaki disease

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China