Heme Arginate in Functional Magnetic Resonance Imaging (f... | NCT01461512

Studies
Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

NCT01461512

Sponsor

MWolzt

Status

Unknown status

Last Update Posted

Oct 28, 2011Estimated

Enrollment

16Actual

Phase

Phase 2

Conditions

Ischemia-reperfusion Injury

Interventions

heme arginate administration
Placebo administration

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Dec 2011Estimated

First Submitted Date

Oct 14, 2011

First Submission Date that Met QC Criteria

Oct 26, 2011

First Posted Date

Oct 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2011

Last Update Posted Date

Oct 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo administration
Heme arginate treatment	Experimental		Drug: heme arginate administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heme arginate administration	Drug	heme arginate 1 mg/kg body weight 24 hours prior to ischemia	Heme arginate treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BOLD MRI signal	functional MRI assessment of blood oxygen level dependent signal strength	2 minutes prior to ischemia till 25 minutes after ischemia
Serum markers of myocellular injury	(myoglobin, creatine-kinase)	24 hours after ischemia

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	in mmHg	20 minutes prior to and 40 minutes after ischemia
Heart rate	in beats per minute	prior to and after ischemia

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

46 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Department of Clinical Pharmacology		Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22857721	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes