We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose

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.


Condition Intervention
Ischemia-Reperfusion Injury Drug: morphine Drug: naloxone Drug: Technetium-TC99m-labeled Annexin A5 Procedure: forearm ischemic exercise Procedure: ten minute forearm ischemia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Opioid Induced Acute Preconditioning

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Percentual difference in Annexin A5 targetting between the experimental and control arm 1 and 4 hours after intravenous injection

Estimated Enrollment: 40
Study Start Date: January 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Exposition to radiation due to imaging techniques in the previous five years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184938


Locations
Netherlands
Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Gerard Rongen, MD, Phd Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00184938     History of Changes
Other Study ID Numbers: OPIRI
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: March 28, 2008
Last Verified: March 2008

Keywords provided by Radboud University:
opioids
ischemic preconditioning
morphine

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Morphine
Analgesics, Opioid
Naloxone
Annexin A5
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action