Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.
研究概览
简要总结
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?
详细描述
Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age between 18-50 yrs
- •signed informed consent
排除标准
- •Cardiovascular disease
- •Hypertension (systole > 140 mmHg, diastole > 90 mmHg)
- •Hypercholesterolemia (fasting total cholesterol > 6,0 mmol/l)
- •Drug abuse
- •Concomitant medication use
- •Inability to perform the ischemic isometric muscle contraction
- •Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
- •Alanine-Amino-Transferase (ALAT) >90U/L (more than twice the upper level of the normal range)
- •Creatinine Kinase (CK) >340U/L (more than twice the upper level of the normal range)
- •Participation in any trial concerning medicinal products during the last 60 days prior to this study.
- •Participation in clinical trial involving
研究组 & 干预措施
1
7 day treatment rosuvastatin
干预措施: Rosuvastatin (Drug)
2
7 day treatment placebo
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.
时间窗: 60 and 240 minutes after ischemic exercise
次要结局
- Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)(during 10 minutes of ischemic exercise)
- The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.(before and after 7day treatment)
- The caffeine serum concentration after 24 hour abstinence .(morning after 24 hours abstinence of caffeine)