Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
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
Sponsor:
Information provided by (Responsible Party):
MWolzt, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE October 14, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date October 28, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)
Official Title  ICMJE The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemia-reperfusion Injury
Intervention  ICMJE
  • Drug: heme arginate administration
    heme arginate 1 mg/kg body weight 24 hours prior to ischemia
  • Drug: Placebo administration
    NaCl isotonic
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo administration
  • Experimental: Heme arginate treatment
    Intervention: Drug: heme arginate administration
Publications * 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;14:55. doi: 10.1186/1532-429X-14-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 26, 2011)
16
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 46 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461512
Other Study ID Numbers  ICMJE Version 1.2 2008-006967-35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MWolzt, Medical University of Vienna
Study Sponsor  ICMJE MWolzt
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP