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Completed

NCT Number: NCT02317913

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 .

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy)
  • bilateral conjunctival congestion
  • changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa
  • polymorphous exanthema
  • changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage
  • 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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 17, 2014
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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