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临床试验/NCT00315510
NCT00315510已完成2 期

Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年4月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
annexin A5 targeting to ischemically exercised hand

研究概览

简要总结

Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent atherosclerotic disease. Recent preclinical evidence suggests that statins also increase tissue tolerance to ischemia-reperfusion injury.

This is a randomized, double blind, parallel designed study comparing the effect of 1 week treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For this purpose, Tc-99m-rh-annexin A5 (400 MBq; < 5 mSv) is injected intravenously upon reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours after injection. Annexin A5 targeting is calculated as the percentage difference in activity (counts/pixel) between the thenar muscles of both hands.

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
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy volunteers (18-50 years of age)

排除标准

  • Hypercholesterolemia
  • Hypertension

结局指标

主要结局

annexin A5 targeting to ischemically exercised hand

次要结局

  • plasma lipid levels

研究者

申办方类型
Other

研究点 (2)

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