Opioid Receptors Influence Ischemia-Reperfusion Injury

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Suspended
• CT.gov ID: NCT00184938
• Collaborator: (none)
• Enrollment: 40
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Ischemia-Reperfusion Injury	Drug: morphine; Drug: naloxone; Drug: Technetium-TC99m-labeled Annexin A5; Procedure: forearm ischemic exercise; Procedure: ten minute forearm ischemia	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Official Title: Opioid Induced Acute Preconditioning
• Study Start Date: Jan 1, 2005

Outcome Measures

Primary Outcome Measures

1. Percentual difference in Annexin A5 targetting between the experimental and control arm 1 and 4 hours after intravenous injection []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

• Exposition to radiation due to imaging techniques in the previous five years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology	Nijmegen	Gelderland	Netherlands	6500 HB

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

• Principal Investigator: Gerard Rongen, MD, Phd, Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00184938
• Other Study ID Numbers: OPIRI
• First Posted: Sep 16, 2005
• Last Update Posted: Mar 28, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: opioids; ischemic preconditioning; morphine
• Additional relevant MeSH terms: Reperfusion Injury; Ischemia; Morphine; Naloxone; Annexin A5

Study Results

No Results Posted as of Mar 28, 2008