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临床试验/NCT00305201
NCT00305201撤回2 期

Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家开始时间: 2006年4月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Percent of change in brachial artery dilatation after statin therapy

研究概览

简要总结

The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.

详细描述

Kawasaki disease (KD) in its acute phase produces endothelial inflammation that can lead to dilatation and aneurysms of coronary and peripheral arteries. This initial injury leads to persistent endothelial dysfunction several years after having the disease. As a consequence, these patients may have a higher cardiovascular risk than general population. Studies with HMG-CoA reductase inhibitors (statins) have suggested that these have an anti-inflammatory effect over the endothelium, that may be independent of its lipid-lowering effects. The hypothesis of this study is that KD produces endothelial dysfunction that is persistent years after acute disease, and that this dysfunction can be modified by treatment with statins.The study consists of two phases. On the first we will perform ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate other cardiovascular risk markers in patients and healthy controls. On the second phase patients with history of Kawasaki disease will be randomized and allocated to treatment with Pravastatin or placebo, after which a new evaluation of flow-mediated dilation of the brachial artery and cardiovascular risk markers will be performed.

Comparison(s): Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment, compared with paired by age children without history of KD or other cardiovascular risk factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
8 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • History of Kawasaki disease more than 12 months before enrollment
  • Present age of 8 years or older

排除标准

  • Diabetes mellitus
  • Not controlled hypertension
  • Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
  • Smokers of more than 5 cigarettes per day
  • Total cholesterol higher than 250 mg/dl
  • Triglycerides higher than 300mg/dl
  • Chronic treatment with statins
  • Chronic renal insufficiency (creatinine > 1.5 mg/dl)

结局指标

主要结局

Percent of change in brachial artery dilatation after statin therapy

次要结局

  • Decrease in LDL
  • Increase in HDL
  • Decrease in triglycerides
  • Decrease in high sensitivity CRP

研究者

申办方类型
Other

研究点 (1)

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