Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

Mucocutaneous Lymph Node Syndrome Clinical Trial

Official title:

Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880929
• Other study ID #: KD EP4
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4533
• Est. completion date: March 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• not in acute phase;

• repeated cases;

Related Conditions & MeSH terms

• Mucocutaneous Lymph Node Syndrome

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: Circulation. 2019 Jul 30;140(5):e181-e184. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of coronary artery lesions	Coronary artery lesions were identified with two-dimensional echocardiography in the acute phase (within one month of onset). Participants were considered to have coronary artery lesions if the luminal diameter of a coronary artery was >3.0 mm in children aged younger than 5 years or >4.0 mm in those aged 5 years and older, or when the internal diameter of a segment was =1.5 times that of an adjacent segment.	from admission to one month after onset
Secondary	Incidence of intravenous immunoglobulin resistance	Ear temperature was measured each day during hospitalization. Intravenous immunoglobulin (IVIG) resistance was defined as persistent fever (>38°C) after 36 hours of completion of initial IVIG infusion or recurrent fever requiring another dose of IVIG or other adjunctive therapies.	from admission to discharge (about two weeks after onset)
Secondary	Risk factors associated with coronary artery lesions	Multivariate logistic regressions were performed to identify risk factors that were independently associated with coronary artery lesions. Odds ratio and 95% CI were calculated for each variable.	from admission to one month after onset