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Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MWolzt, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01461512
First received: October 14, 2011
Last updated: October 26, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Ischemia-reperfusion Injury
 Drug: heme arginate administration
Drug: Placebo administration
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • BOLD MRI signal [ Time Frame: 2 minutes prior to ischemia till 25 minutes after ischemia ] [ Designated as safety issue: No ]
    functional MRI assessment of blood oxygen level dependent signal strength

  • Serum markers of myocellular injury [ Time Frame: 24 hours after ischemia ] [ Designated as safety issue: Yes ]
    (myoglobin, creatine-kinase)


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 20 minutes prior to and 40 minutes after ischemia ] [ Designated as safety issue: Yes ]
    in mmHg

  • Heart rate [ Time Frame: prior to and after ischemia ] [ Designated as safety issue: Yes ]
    in beats per minute


Enrollment: 16
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461512

Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
MWolzt
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MWolzt, Prof. Dr. Michael Wolzt, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01461512     History of Changes
Other Study ID Numbers: Version 1.2 2008-006967-35
Study First Received: October 14, 2011
Last Updated: October 26, 2011
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
 Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on May 16, 2013