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Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317913
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : March 10, 2016
Sponsor:
Collaborators:
Children's Hospital of Shanghai Jiao Tong University
Shanghai Children's Medical Center
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
Shanghai 6th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Changhai Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Information provided by (Responsible Party):
Guoying huang, 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 .

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 2402 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012
Study Start Date : April 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease




Primary Outcome Measures :
  1. incidence of coronary artery lesions(CAL) [ Time Frame: 5 years ]
    according to the result of the echocardiography performed in the acute phase ,early and late recovery of Kawasaki disease



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients with KD diagnosed during January 2008 through December 2012 in Shanghai
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317913


Locations
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China, Shanghai
Children Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Children's Hospital of Shanghai Jiao Tong University
Shanghai Children's Medical Center
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
Shanghai 6th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Changhai Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guoying huang, Professor,President, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02317913     History of Changes
Other Study ID Numbers: kd2008-2012
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2015
Keywords provided by Guoying huang, Children's Hospital of Fudan University:
Kawasaki disease
Epidemiology
Incidence
Coronary arterial lesions
Shanghai
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases