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

This study has been withdrawn prior to enrollment.
(new insights have let us to expect marginal annexin targeting with a 10 minutes delay between reperfusion and administration of Annexin A5)
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00441714
First received: February 28, 2007
Last updated: October 25, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention
Cardiovascular Disease
Ischemia-Reperfusion Injury
Postconditioning
 Procedure: repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

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

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

Estimated Enrollment: 20
Study Start Date: October 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441714

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

Publications:

ClinicalTrials.gov Identifier: NCT00441714     History of Changes
Other Study ID Numbers: IPost
Study First Received: February 28, 2007
Last Updated: October 25, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 19, 2013