Atherosclerosis Clinical Trial
Official title:
Does a Seven Day Treatment With Dipyridamole Induce Protection Against Ischemia-Reperfusion Injury?
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.
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.
Study population:
Healthy male volunteers, aged 18-50 yr
Intervention:
10 Volunteers will be randomised to receive in a cross-over design either a 7 day treatment
with dipyridamole (Persantin retard; 200 mg twice daily) or placebo followed by 10 minutes
of ischemic isometric muscle contraction of the non-dominant forearm and upon reperfusion
infusion of radiolabeled Annexin A5 (Annexin scintigraphy).
Main study parameters/endpoints:
Percentage difference in radioactivity (counts/pixel) between experimental and control
thenar muscle at 60 and 240 minutes after reperfusion.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
This study will be executed at the Clinical Research Centre Nijmegen under close medical
supervision. Treatment with dipyridamole is not expected to harm the volunteers. During the
first days of treatment with dipyridamole, a headache may occur. Ischemic hand gripping will
temporarily result in pain in the forearm. This is completely reversible upon reperfusion.
Administration of radiolabeled Annexin A5 results in an effective dose of less than 5 mSv,
well within the range of accepted exposure to radioactivity for human research.
Participation in this research does not interfere with possible diagnostic or therapeutic
procedures with X-rays of radioactivity in the future.
Occurrence of an allergic reaction is theoretically possible upon administration of Annexin
A5, however there have been no allergic reactions reported in all volunteers exposed to
Annexin A5.
The volunteers will not benefit directly from participating in this study.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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