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Completed

NCT Number: NCT00430170

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

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

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Ischemia-Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500hb, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age between 18-50yr.

Exclusion criteria

  • 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.

Treatment and study plan

dipyridamole

Drug

Dipyridamole 2x200mg 7day per os

Other names: persatin

Caffeine

Drug

caffeine 4mg/kg iv

Primary outcomes

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

    Time frame: 60 and 240 minutes after ischemic exercise

Secondary outcomes

  1. Plasma dipyridamole concentration

    Time frame: at the morning of day 7 of treatment with dipyridamole/placebo

  2. ENT transport activity (before and after treatment with dipyridamole 200mg, twice daily, for seven days)

    Time frame: before start of treatment (dipyridamol/placebo) and in the morning of day 7 of treatment (placebo/dipyridamol)

  3. Workload (duration of exercise and developed force)

    Time frame: during 10 minutes of ischemic exercise

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 1, 2007
Registry last updated
Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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