Does a Seven Day Treatment With Dipyridamole Induce Protection Against Ischemia-Reperfusion Injury?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion.
研究概览
简要总结
This study is performed to determine whether a seven day treatment with dipyridamole (slow release, 200mg twice daily) can induce a protective effect against ischemia-reperfusion injury, after ischemic exercise of the non-dominant forearm in healthy volunteers.
详细描述
Rationale:
Dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ENT-1). Activation of the adenosine receptor protects against ischemia-reperfusion injury (pharmacologic preconditioning).
The purpose of this project is to explore whether a seven day treatment with dipyridamole can reduce ischemia-reperfusion injury in the forearm, in a randomized double blind placebo controlled trial.
Study design:
Randomized double-blind placebo-controlled trial with a cross-over design.
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 between 18-50yr.
排除标准
- •cardiovascular disease
- •hypertension (systole > 140 mmHg, diastole > 90 mmHg)
- •hypercholesterolemia (fasting total cholesterol > 5.5 mmol/l or not fasting total cholesterol > 6.5mmol/L)
- •diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
- •asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
- •participation in any clinical trial during the last 60 days prior to this study.
- •administration of any radioactivity for research purposes during the last 5 years prior to this study.
- •concomitant medication
研究组 & 干预措施
1
first 7 day treatment with dipyridamol and at least two weeks later 7 day treatment with placebo
干预措施: dipyridamole (Drug)
2
first 7 day treatment with placebo and at least two weeks later 7 day treatment with atorvastatin
干预措施: dipyridamole (Drug)
结局指标
主要结局
Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion.
时间窗: 60 and 240 minutes after reperfusion
次要结局
- Plasma dipyridamole concentration(in the morning of day seven of treatment)
- Workload (duration of exercise and developed force)(during 10 minutes ischemic exercise)
- Heart rate (preceded by a 7day treatment of dipyridamol or placebo)(during 30 minutes at day seven of treatment with dipyridamol and placebo)