Clinical trial NCT02317913: Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012
Official title: Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kawasaki Disease
Keywords: Kawasaki disease
Epidemiology
Incidence
Coronary arterial lesions
Shanghai
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Ruijin Hospital
name: Shanghai 6th People's Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Changhai Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2014-12-17
Enrollment: 2402
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with KD diagnosed during January 2008 through December 2012 in Shanghai

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.

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

Primary outcomes:
measure: incidence of coronary artery lesions(CAL)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: 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.