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临床试验/NCT03750123
NCT03750123已完成不适用

Cardiovascular Status of Children 5 Years After Kawasaki Disease

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Central blood pressure in children 5 years after KD

研究概览

简要总结

The aim of present study is to determine cardiovascular status of children who had KD in past and to identify possible biochemical markers of cardiovascular damage in those patients.

In this cross-sectional study children with history of KD will be examined 5 years after receiving intravenous immunoglobulin treatment (IVIG) and compared to healthy controls in terms of: serum levels of endothelial injury markers (circulating endothelial cells, galectin-3, soluble VCAM), peripheral blood pressure, central blood pressure, arterial stiffness parameters (measured by applanation tonometry), carotid intima media thickness (cIMT), capillaroscopy and echocardiography.

详细描述

All participants will be examined in Medical University Warsaw Children's Hospital.

Children with history of KD will be recruited from 2 paediatric hospitals in Warsaw and via advertisement by Polish support group for parents of children with KD in social media. Diagnosis of KD will be verified according to current American Heart Association (AHA) guidelines.

All children after KD will be examined 5 years after IVIG treatment exact to 2 months.

CAA presence at the time of KD diagnosis will be determined on the basis of medical records, after specialist consultation, in accordance to AHA definition. Worst-ever echocardiographic picture of coronary arteries will be considered in analysis.

Healthy age- and sex-matched controls (HC) will be recruited from KD patients' siblings.

研究设计

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

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • history of KD treated with intravenous immunoglobulin (IVIG)

排除标准

  • any significant comorbidities,
  • body mass index (BMI) value > 1 standard deviation (SD) for age and gender,
  • height < 120 cm at the time of cardiovascular assessment.

研究组 & 干预措施

Kawasaki Disease (KD)

Children 5 years after Kawasaki Disease

Healthy controls (HC)

Age- and sexmatched healthy siblings of children after Kawasaki Disease

结局指标

主要结局

Central blood pressure in children 5 years after KD

时间窗: 5 years

comparison of central blood pressure values in KD and HC groups

Arterial stiffness in children 5 years after KD

时间窗: 5 years

comparison of pulse wave velocity Z-score in KD and HC groups

CEC in children 5 years after KD

时间窗: 5 years

comparison of CEC number in KD and HC groups

次要结局

  • Diastolic function of the left ventricle in children 5 years after KD(5 years)
  • VEGF in children 5 years after KD(5 years)
  • Capillaroscopy in children 5 years after KD(5 years)
  • Soluble E-selectin in children 5 years after KD(5 years)
  • Endocan in children 5 years after KD(5 years)
  • Thrombomodulin in children 5 years after KD(5 years)
  • Left ventricle size in children 5 years after KD(5 years)
  • cIMT in children 5 years after KD(5 years)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magdalena Okarska-Napierała

Principal Investigator

Medical University of Warsaw

研究点 (2)

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