Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

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

Study Overview

• Status: Completed
• Conditions: Kawasaki Disease

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 Type: Observational
• Enrollment (Actual): 2402

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with KD diagnosed during January 2008 through December 2012 in Shanghai

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Changhai Hospital; Ruijin Hospital; Shanghai Children's Medical Center; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Tongji Hospital, Tongji University School of Medicine; Shanghai 6th People's Hospital

Publications and helpful links

General Publications

• Chen JJ, Ma XJ, Liu F, Yan WL, Huang MR, Huang M, Huang GY; Shanghai Kawasaki Disease Research Group. Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012. Pediatr Infect Dis J. 2016 Jan;35(1):7-12. doi: 10.1097/INF.0000000000000914.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Epidemiology; Incidence; Shanghai; Kawasaki disease; Coronary arterial lesions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: kd2008-2012