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Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
MWolzt, Medical University of Vienna

Brief Summary:
Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1 induction during short-time ischemia in skeletal muscle of healthy subjects.

Condition or disease Intervention/treatment Phase
Ischemia-reperfusion Injury Drug: heme arginate administration Drug: Placebo administration Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo administration
NaCl isotonic

Experimental: Heme arginate treatment Drug: heme arginate administration
heme arginate 1 mg/kg body weight 24 hours prior to ischemia

Primary Outcome Measures :
  1. 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

  2. Serum markers of myocellular injury [ Time Frame: 24 hours after ischemia ]
    (myoglobin, creatine-kinase)

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 20 minutes prior to and 40 minutes after ischemia ]
    in mmHg

  2. Heart rate [ Time Frame: prior to and after ischemia ]
    in beats per minute

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent
  • 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:

  • Known hypersensitivity to the study drug or any excipients of the drug formulation
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01461512

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Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MWolzt, Prof. Dr. Michael Wolzt, Medical University of Vienna Identifier: NCT01461512    
Other Study ID Numbers: Version 1.2 2008-006967-35
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications