NCT02317913

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

December 8, 2014

Last Update Submit

March 8, 2016

Conditions

Keywords

Kawasaki diseaseEpidemiologyIncidenceCoronary arterial lesionsShanghai

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients with KD diagnosed during January 2008 through December 2012 in Shanghai

You may qualify if:

  • 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

You may not qualify if:

  • The cases were not in accordance with the recruited criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,President

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 17, 2014

Study Start

April 1, 2013

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

March 10, 2016

Record last verified: 2015-03

Locations