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This study has been withdrawn prior to enrollment.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

February 28, 2007
October 25, 2007
October 2007
Not Provided
Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
Same as current
Complete list of historical versions of study NCT00441714 on ClinicalTrials.gov Archive Site
Workload during (ischemic) exercise.
Same as current
Not Provided
Not Provided
 
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cardiovascular Disease
  • Ischemia-Reperfusion Injury
  • Postconditioning
Procedure: repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
December 2007
Not Provided

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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00441714
IPost
No
Not Provided
Radboud University
Not Provided
Principal Investigator: Gerard Rongen, MD PhD RUMCN
Radboud University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP