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临床试验/NCT03880929
NCT03880929已完成不适用

Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 4,533 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,533
试验地点
1
主要终点
Incidence of coronary artery lesions

研究概览

简要总结

To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.

详细描述

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.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • not in acute phase;
  • repeated cases;

结局指标

主要结局

Incidence of coronary artery lesions

时间窗: from admission to one month after onset

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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