Clinical trial NCT03880929: Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
Official title: Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucocutaneous Lymph Node Syndrome
Keywords: kawasaki disease
coronary artery lesion
epidemiology
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Shanghai Children's Medical Center
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2019-03-19
Enrollment: 4533
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospitalized patients diagnosed with Kawasaki disease in Shanghai from 2013 through 2017

Brief summary: To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.

Detailed description: Based on the KD research group network established during the first survey in Shanghai, a set of questionnaires and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. Medical records of participants with KD diagnosed from January 2013 through December 2017 will be retrospectively analyzed. Data are collected by pediatricians, including demographic information, clinical manifestations, prognosis, laboratory indexes, treatment and echocardiographic findings.

Age and seasonal distribution at onset, treatment and cardiac abnormalities wil be described. Univariate and multivariate analyses will be performed to identify risk factors for coronary artery lesions.

Eligibility criteria: Inclusion Criteria:

- meeting the diagnostic criteria for Kawasaki disease released by American Heart Association 2017

Exclusion Criteria:

* not in acute phase;
* repeated cases;

Primary outcomes:
measure: Incidence of coronary artery lesions
timeFrame: from admission to one month after onset
Secondary outcomes:
measure: Incidence of intravenous immunoglobulin resistance
timeFrame: from admission to discharge (about two weeks after onset)
measure: Risk factors associated with coronary artery lesions
timeFrame: from admission to one month after onset
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Fang Liu, Dr.
role: PRINCIPAL_INVESTIGATOR
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.
citation: McCrindle BW, Rowley AH, Newburger JW, Burns JC, Bolger AF, Gewitz M, Baker AL, Jackson MA, Takahashi M, Shah PB, Kobayashi T, Wu MH, Saji TT, Pahl E; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Epidemiology and Prevention. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017 Apr 25;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. Epub 2017 Mar 29.
citation: JCS Joint Working Group. Guidelines for diagnosis and management of cardiovascular sequelae in Kawasaki disease (JCS 2008)--digest version. Circ J. 2010 Sep;74(9):1989-2020. doi: 10.1253/circj.cj-10-74-0903. Epub 2010 Aug 18. No abstract available.