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临床试验/NCT00952770
NCT00952770Unknown4 期

Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty

Chungnam National University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
4 期
入组人数
140
试验地点
1
主要终点
Difference of IMT between two groups

研究概览

简要总结

The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing coronary intervention via the radial artery

排除标准

  • Contraindication to statins
  • Left ventricular ejection fraction less than 30%
  • Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
  • Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
  • History of renal dysfunction or a serum creatinine level >2.0 mg/dL
  • Serious noncardiac comorbid disease with a life expectancy <1 year
  • Inability to follow the protocol

结局指标

主要结局

Difference of IMT between two groups

时间窗: 1 month, 6 months

次要结局

  • Difference of epicardial fat thickness Difference of cholesterol level(6 months)

研究者

申办方类型
Other

研究点 (1)

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