Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)
NCT ID: NCT01461512
Last Updated: 2011-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
16 participants
INTERVENTIONAL
2009-01-31
2011-12-31
Brief Summary
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Detailed Description
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Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) can measure alterations in tissue oxygenation in a high spatial and temporal resolution. This non-invasive methods therefore represent a promising technique to evaluate the effects of HO-1 induction on energy metabolism and oxygen saturation during ischemic stress and short time reperfusion in skeletal muscle.
As additional outcome, levels of myoglobin and creatine-kinase will be measured in plasma according to standard laboratory procedures.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo administration
NaCl isotonic
Heme arginate treatment
heme arginate administration
heme arginate 1 mg/kg body weight 24 hours prior to ischemia
Interventions
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heme arginate administration
heme arginate 1 mg/kg body weight 24 hours prior to ischemia
Placebo administration
NaCl isotonic
Eligibility Criteria
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Inclusion Criteria
* Men aged between 18 and 46 years (inclusive)
* Nonsmoker for more than 3 months
* Body mass index between 18 and 27 kg/m2
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Negative results from urine drug screen if performed
* Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study
Exclusion Criteria
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment with another investigational drug within 3 weeks prior to screening
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
* Treatment in the previous 3 weeks with any drug including over-the-counter drugs (including herbal medicines such as St John's Wort)
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Blood donation during the previous 3 weeks
* Any metallic, electric, electronic or magnetic device or object not removable
* Claustrophobia
18 Years
46 Years
MALE
Yes
Sponsors
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MWolzt
OTHER
Responsible Party
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MWolzt
Prof. Dr. Michael Wolzt
Locations
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Medical University of Vienna, Department of Clinical Pharmacology
Vienna, , Austria
Countries
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References
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Andreas M, Schmid AI, Doberer D, Schewzow K, Weisshaar S, Heinze G, Bilban M, Moser E, Wolzt M. Heme arginate improves reperfusion patterns after ischemia: a randomized, placebo-controlled trial in healthy male subjects. J Cardiovasc Magn Reson. 2012 Aug 2;14(1):55. doi: 10.1186/1532-429X-14-55.
Other Identifiers
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Version 1.2 2008-006967-35
Identifier Type: -
Identifier Source: org_study_id