NCT03880929

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,533

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

June 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

March 6, 2019

Last Update Submit

July 3, 2023

Conditions

Mucocutaneous Lymph Node Syndrome

Keywords

kawasaki diseasecoronary artery lesionepidemiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of intravenous immunoglobulin resistance

    from admission to discharge (about two weeks after onset)

  • Risk factors associated with coronary artery lesions

    from admission to one month after onset

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All hospitalized patients diagnosed with Kawasaki disease in Shanghai from 2013 through 2017

You may qualify if:

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

You may not qualify if:

  • not in acute phase;
  • repeated cases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201122, China

Location

Related 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.

    PMID: 26372452BACKGROUND

  • 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.

    PMID: 28356445BACKGROUND

  • 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.

    PMID: 20724794BACKGROUND

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 Officials

  • Fang Liu, Dr.

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 19, 2019

Study Start

June 1, 2017

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)