Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)
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|ClinicalTrials.gov Identifier: NCT01461512|
Recruitment Status : Unknown
Verified October 2011 by MWolzt, Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : October 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Ischemia-reperfusion Injury||Drug: heme arginate administration Drug: Placebo administration||Phase 2|
Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. The investigators previous data confirmed strong HO-1 induction following heme arginate infusion in healthy humans. Therefore, the investigators next approach is to evaluate the direct effects of heme arginate on short time Ischemia-reperfusion (IR) injury in healthy humans. This will be done by the following surrogate markers of IR injury.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||December 2011|
|Placebo Comparator: Placebo||
Drug: Placebo administration
|Experimental: Heme arginate treatment||
Drug: heme arginate administration
heme arginate 1 mg/kg body weight 24 hours prior to ischemia
- BOLD MRI signal [ Time Frame: 2 minutes prior to ischemia till 25 minutes after ischemia ]functional MRI assessment of blood oxygen level dependent signal strength
- Serum markers of myocellular injury [ Time Frame: 24 hours after ischemia ](myoglobin, creatine-kinase)
- Blood pressure [ Time Frame: 20 minutes prior to and 40 minutes after ischemia ]in mmHg
- Heart rate [ Time Frame: prior to and after ischemia ]in beats per minute
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461512
|Medical University of Vienna, Department of Clinical Pharmacology|
|Vienna, Austria, 1090|