Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Kawasaki Disease Clinical Trial

Official title:

Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317913
• Other study ID #: kd2008-2012
• 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

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

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