Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

Sponsor

MWolzt (Other)

Overall Status

Unknown status

CT.gov ID

NCT01461512

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

BOLD MRI signal [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 [24 hours after ischemia]
(myoglobin, creatine-kinase)

Secondary Outcome Measures

Blood pressure [20 minutes prior to and 40 minutes after ischemia]
in mmHg
Heart rate [prior to and after ischemia]
in beats per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 46 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Clinical Pharmacology	Vienna		Austria	1090

Sponsors and Collaborators

MWolzt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MWolzt, Prof. Dr. Michael Wolzt, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01461512

Other Study ID Numbers:

Version 1.2 2008-006967-35

First Posted:

Oct 28, 2011

Last Update Posted:

Oct 28, 2011

Last Verified:

Oct 1, 2011

Additional relevant MeSH terms:

Reperfusion Injury

Ischemia

Study Results

No Results Posted as of Oct 28, 2011