Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise

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. Identifier: NCT00441714
Recruitment Status : Withdrawn (new insights have let us to expect marginal annexin targeting with a 10 minutes delay between reperfusion and administration of Annexin A5)
First Posted : March 1, 2007
Last Update Posted : November 10, 2015
Information provided by:
Radboud University

Brief Summary:

To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients.

To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Ischemia-reperfusion Injury Postconditioning Procedure: repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise Not Applicable

Detailed Description:
Recently, ischemic postconditioning has been identified as a protective intervention against ischemia-reperfusion injury. In animal studies, the signalling pathway of this (impressive) protective phenomenon is very similar to ischemic preconditioning. It opens a new avenue of post-reperfusion interventions with drugs that have been shown to mimic ischemic preconditioning. Before we can study this phenomenon in our forearm ischemia-reperfusion model, we need additional validating experiments. The purpose of this study proposal is to provide these data.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Study Start Date : October 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.

Secondary Outcome Measures :
  1. Workload during (ischemic) exercise.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18-50 years
  • No physical limitation to perform ischemic exercise
  • Informed consent

Exclusion Criteria:

  • Diabetes (fasting glucose > 7,0mmol/l, or random glucose >11,0mmol/l)
  • hyperlipidemia (random total cholesterol > 6.5 mmol/l)
  • Hypertension (supine SBP/DBP > 140/90 mmHg at screening)
  • Any cardiovascular disease
  • Drug abuse
  • Concomitant chronic use of medication
  • Administration of radioactivity in research setting during the last 5 years
  • Participation to any drug-investigation during the previous month as checked with VIP check according to CRCN standard procedures.

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 identifier (NCT number): NCT00441714

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Gerard Rongen, MD PhD RUMCN

Publications: Identifier: NCT00441714     History of Changes
Other Study ID Numbers: IPost
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Radboud University:
cardiovascular disease
ischemia-reperfusion injury
annexin targeting

Additional relevant MeSH terms:
Cardiovascular Diseases
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Postoperative Complications
Annexin A5
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action