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临床试验/NCT05434611
NCT05434611Unknown不适用

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

The First Affiliated Hospital of Yangtze University0 个研究点目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
S100A12

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

S100A12

时间窗: 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

次要结局

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

研究者

发起方
The First Affiliated Hospital of Yangtze University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pan Yan

Attending physician

The First Affiliated Hospital of Yangtze University

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