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Clinical Trials/NCT05434611
NCT05434611UnknownNot Applicable

Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease

The First Affiliated Hospital of Yangtze University0 sites100 target enrollmentStarted: July 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Primary Endpoint
S100A12

Study Overview

Brief Summary

Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence phase before gradually decreasing. However, the number of patients included in previous studies was small and the follow-up time was short. In this study, 100 children with Kawasaki disease who were admitted to Wuhan Children's Hospital, Jingzhou First People's Hospital and Renhe Hospital affiliated to China Three Gorges University from December 2021 to December 2023 were selected as the research objects, and 100 children with healthy physical examination were selected as the control group during the same period. To investigate whether S100A12 increased significantly in the acute phase of Kawasaki disease compared with a healthy control group. To study whether S100A12 value increased rather than decreased in kawasaki disease that did not respond to gamma globulin treatment after gamma globulin treatment. At the same time, to study whether the increase of S100A12 in kawasaki disease convalescence indicates coronary aneurysm.

Detailed Description

S100A12 was determined using the ELISA kit and according to the instructions.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • ▪Diagnostic criteria of Kawasaki disease revised by the American Heart Association in 2017

Exclusion Criteria

  • Scarlet fever
  • Drug allergy syndrome
  • Stevens-Johnson syndrome
  • Toxic shock syndrome
  • Adenovirus infection
  • Epstein-Barr(EB) virus infection

Outcomes

Primary Outcomes

S100A12

Time Frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months

S100A12 was increased in children with Kawasaki disease and decreased after gamma globulin treatment

Secondary Outcomes

  • CRP(From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months)

Investigators

Sponsor
The First Affiliated Hospital of Yangtze University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pan Yan

Attending physician

The First Affiliated Hospital of Yangtze University

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