Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.
研究概览
简要总结
To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.
详细描述
3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been found to reduce cardiovascular events. This protective effect has been traditionally explained by lowering plasma cholesterol and subsequent reduced progression of atherosclerosis. However in animal experiments statins have also shown the ability to induce pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the beneficial effect of statins on reducing of cardiovascular events. In order to differentiate between these two mechanisms of protection we will study the effect of atorvastatin on ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering effect of atorvastatin becomes apparent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 18-50 years
- •Informed consent
- •Physical able to perform ischemic exercise
排除标准
- •History of any cardiovascular disease
- •Hypertension (in supine position: systole > 140 mmHg, diastole > 90 mmHg)
- •Diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
- •Hyperlipidaemia (fasting total cholesterol > 5.5 mmol/l)
- •Alanine-Amino-Transferase (ALAT) >90 U/L
- •Creatinine Kinase (CK) >440 U/L
- •Drug or alcohol abuse
- •Concommitant chronic use of medication
- •Administration of radioactivity in research setting during the last 5 years
- •Participation to any drug-investigation during the previous 60 days as checked with VIP check according to CRCN standard procedures
研究组 & 干预措施
1
first 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg
干预措施: atorvastatin (Drug)
2
first 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo
干预措施: atorvastatin (Drug)
结局指标
主要结局
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.
时间窗: 60 and 240 minutes after ischemic exercise
次要结局
- workload during ischemic exercise(workload during 10minutes of ischemic exercise)
- effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels(fasting lipid levels before and at first day after 3 day treatment with atorvastatin)