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Rosuvastatin and Ischemia Reperfusion

Primary Purpose

Ischemia

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia focused on measuring Ischemia-reperfusion, Annexin A5

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteers (18-50 years of age) Exclusion Criteria: Hypercholesterolemia Hypertension

Sites / Locations

  • Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

annexin A5 targeting to ischemically exercised hand

Secondary Outcome Measures

plasma lipid levels

Full Information

First Posted
April 14, 2006
Last Updated
September 22, 2008
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00315510
Brief Title
Rosuvastatin and Ischemia Reperfusion
Official Title
Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
Ischemia-reperfusion, Annexin A5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
annexin A5 targeting to ischemically exercised hand
Secondary Outcome Measure Information:
Title
plasma lipid levels

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: Healthy volunteers (18-50 years of age) Exclusion Criteria: Hypercholesterolemia Hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard A. Rongen, MD, PhD
Organizational Affiliation
Dept. of Pharmacology-Toxicology; Radboud University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
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
background
PubMed Identifier
19359665
Citation
Meijer 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.
Results Reference
derived

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Rosuvastatin and Ischemia Reperfusion

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