NCT00184938

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

First QC Date

September 12, 2005

Last Update Submit

March 27, 2008

Conditions

Keywords

opioidsischemic preconditioningmorphine

Outcome Measures

Primary Outcomes (1)

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

Interventions

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.

    PMID: 15623546BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury

Interventions

MorphineNaloxone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Gerard Rongen, MD, Phd

    Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations