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临床试验/NCT00430170
NCT00430170已完成4 期

Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury?

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Percentage difference in Annexin A5 targetting between experimental and control thenar muscle at 60 and 240 minutes after reperfusion

研究概览

简要总结

The purpose of this project is to explore the interaction between caffeine and dipyridamole on ischemia-reperfusion injury in the forearm.

详细描述

Dipyridamole has been proven to reduce targeting of Annexin A5 in responses to ischemic exercise, indicating protection against ischemia-reperfusion injury in humans (pharmacological preconditioning). Dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ENT-1). Activation of the adenosine receptor protects against ischemia-reperfusion injury. We hypothesize that endogenous adenosine mediates the protective effect of dipyridamole against ischemia-reperfusion injury. Therefore the adenosine receptor antagonist caffeine will reduce the benefit of dipyridamole on forearm ischemia-reperfusion injury.

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
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

入选标准

  • Age between 18-50yr.

排除标准

  • cardiovascular disease
  • hypertension (systole > 140 mmHg, diastole > 90 mmHg)
  • hypercholesterolemia (random total cholesterol > 6.5 mmol/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 two doses of Annexin A5 (0,1mg; 450MBq) during the last 5 years prior to this study.

研究组 & 干预措施

1

Active Comparator

dipyridamol during 7 days and before ischemic exercise caffeine 4mg/kg

干预措施: Dipyridamole (Drug)

1

Active Comparator

dipyridamol during 7 days and before ischemic exercise caffeine 4mg/kg

干预措施: caffeine (Drug)

2

Placebo Comparator

dipyridamol during 7 days and before ischemic exercise placebo

干预措施: Dipyridamole (Drug)

结局指标

主要结局

Percentage difference in Annexin A5 targetting between experimental and control thenar muscle at 60 and 240 minutes after reperfusion

时间窗: 60 and 240 minutes after ischemic exercise

次要结局

  • Plasma dipyridamole concentration(at the morning of day 7 of treatment with dipyridamole/placebo)
  • ENT transport activity (before and after treatment with dipyridamole 200mg, twice daily, for seven days)(before start of treatment (dipyridamol/placebo) and in the morning of day 7 of treatment (placebo/dipyridamol))
  • Workload (duration of exercise and developed force)(during 10 minutes of ischemic exercise)

研究者

申办方类型
Other

研究点 (1)

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