Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise - Full Text View

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00441714

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

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise

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:

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.

Study ID Numbers:	IPost
Study First Received:	February 28, 2007
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00441714
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

Study placed in the following topic categories:

Postoperative Complications
Vascular Diseases
Annexin A5
Ischemia
Reperfusion Injury

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009