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Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

Primary Purpose

Ischemia-reperfusion Injury

Status

Unknown status

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

heme arginate administration

Placebo administration

About this trial

This is an interventional treatment trial for Ischemia-reperfusion Injury

Eligibility Criteria

18 Years - 46 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Medical University of Vienna, Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Heme arginate treatment

Arm Description

Outcomes

Primary Outcome Measures

BOLD MRI signal

functional MRI assessment of blood oxygen level dependent signal strength

Serum markers of myocellular injury

(myoglobin, creatine-kinase)

Secondary Outcome Measures

Blood pressure

in mmHg

Heart rate

in beats per minute

Full Information

NCT ID

NCT01461512

First Posted

October 14, 2011

Last Updated

October 26, 2011

Sponsor

MWolzt

1. Study Identification

Unique Protocol Identification Number

NCT01461512

Brief Title

Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

Official Title

The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

MWolzt

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemia-reperfusion Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Heme arginate treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

heme arginate administration

Intervention Description

heme arginate 1 mg/kg body weight 24 hours prior to ischemia

Intervention Type

Drug

Intervention Name(s)

Placebo administration

Intervention Description

NaCl isotonic

Primary Outcome Measure Information:

Title

BOLD MRI signal

Description

functional MRI assessment of blood oxygen level dependent signal strength

Time Frame

2 minutes prior to ischemia till 25 minutes after ischemia

Title

Serum markers of myocellular injury

Description

(myoglobin, creatine-kinase)

Time Frame

24 hours after ischemia

Secondary Outcome Measure Information:

Title

Blood pressure

Description

in mmHg

Time Frame

20 minutes prior to and 40 minutes after ischemia

Title

Heart rate

Description

in beats per minute

Time Frame

prior to and after ischemia

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

46 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Medical University of Vienna, Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

22857721

Citation

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.

Results Reference

derived

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Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

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