- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441714
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
November 9, 2015 updated by: Radboud University Medical Center
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.
Study Overview
Status
Withdrawn
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
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nijmegen, Netherlands, 6500HB
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
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Secondary Outcome Measures
Outcome Measure |
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Workload during (ischemic) exercise.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gerard Rongen, MD PhD, RUMCN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Completion (Anticipated)
December 1, 2007
Study Registration Dates
First Submitted
February 28, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Estimate)
November 10, 2015
Last Update Submitted That Met QC Criteria
November 9, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPost
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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