Rosuvastatin and Ischemia Reperfusion
Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent atherosclerotic disease. Recent preclinical evidence suggests that statins also increase tissue tolerance to ischemia-reperfusion injury. This is a randomized, double blind, parallel designed study comparing the effect of 1 week treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For this purpose, Tc-99m-rh-annexin A5 (400 MBq; \< 5 mSv) is injected intravenously upon reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours after injection. Annexin A5 targeting is calculated as the percentage difference in activity (counts/pixel) between the thenar muscles of both hands.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 14, 2006
CompletedFirst Posted
Study publicly available on registry
April 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedSeptember 23, 2008
September 1, 2008
April 14, 2006
September 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
annexin A5 targeting to ischemically exercised hand
Secondary Outcomes (1)
plasma lipid levels
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers (18-50 years of age)
You may not qualify if:
- Hypercholesterolemia
- Hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB, Netherlands
Related Publications (2)
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.
PMID: 15623546BACKGROUNDMeijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.
PMID: 19359665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerard A. Rongen, MD, PhD
Dept. of Pharmacology-Toxicology; Radboud University Medical Centre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 14, 2006
First Posted
April 18, 2006
Study Start
April 1, 2006
Study Completion
August 1, 2007
Last Updated
September 23, 2008
Record last verified: 2008-09