Back to resultsEffect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Primary Purpose
Cardiovascular Disease, Ischemia-reperfusion Injury, Postconditioning
Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiovascular Disease focused on measuring cardiovascular disease, ischemia-reperfusion injury, postconditioning, annexin targeting
Eligibility 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.
Sites / Locations
- Radboud University Nijmegen Medical Centre
Outcomes
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.
Full Information
NCT ID
NCT00441714
First Posted
February 28, 2007
Last Updated
November 9, 2015
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00441714
Brief Title
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Official Title
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
new insights have let us to expect marginal annexin targeting with a 10 minutes delay between reperfusion and administration of Annexin A5
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Ischemia-reperfusion Injury, Postconditioning
Keywords
cardiovascular disease, ischemia-reperfusion injury, postconditioning, annexin targeting
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise
Primary Outcome Measure Information:
Title
Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
Secondary Outcome Measure Information:
Title
Workload during (ischemic) exercise.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Rongen, MD PhD
Organizational Affiliation
RUMCN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
15623546
Citation
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.
Results Reference
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Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
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