Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

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Brief Title

Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Official Title

Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

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 Type

Observational


Primary Outcome

incidence of coronary artery lesions(CAL)


Condition

Kawasaki Disease



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2402

Start Date

April 2013

Completion Date

January 2016

Primary Completion Date

November 2015

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02317913

Organization ID

kd2008-2012


Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Fudan University

Collaborators

 Shanghai Children's Medical Center

Study Sponsor

, , 


Verification Date

March 2015