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Opioid Receptors Influence Ischemia-Reperfusion Injury

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184938
First Posted: September 16, 2005
Last Update Posted: March 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
September 12, 2005
September 16, 2005
March 28, 2008
January 2005
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Percentual difference in Annexin A5 targetting between the experimental and control arm 1 and 4 hours after intravenous injection
Percentual difference in Annexin A5 targetting between the experimental and control arm 1 and 4 hours after intravenous injection.
Complete list of historical versions of study NCT00184938 on ClinicalTrials.gov Archive Site
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Opioid Receptors Influence Ischemia-Reperfusion Injury
Opioid Induced Acute Preconditioning

The most powerful protective mechanism against ischemia-reperfusion injury other than rapid reperfusion is ischemic preconditioning. Ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia resulting in a marked reduction in infarct size. This mechanism can be mimicked by several pharmacological substances such as adenosine and morphine.

We, the researchers at Radboud University Nijmegen Medical Centre, have recently developed a method in which we can detect ischemia-reperfusion injury in the human forearm by using Annexin A5 scintigraphy (Rongen et al). With this method we will determine whether opioid receptors are involved in ischemic preconditioning. We expect to find that morphine can mimic ischemic preconditioning and that acute ischemic preconditioning can be blocked with the opioid receptor antagonist naloxon. This study will increase our knowledge about the mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous protective mechanism in a clinical setting.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Ischemia-Reperfusion Injury
  • Drug: morphine
  • Drug: naloxone
  • Drug: Technetium-TC99m-labeled Annexin A5
  • Procedure: forearm ischemic exercise
  • Procedure: ten minute forearm ischemia
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Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. Epub 2004 Dec 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
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Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Exposition to radiation due to imaging techniques in the previous five years
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00184938
OPIRI
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Radboud University
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Principal Investigator: Gerard Rongen, MD, Phd Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
Radboud University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP