NCT01461512

Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: MWolzt · Academic / Other
• Sex: Male
• Age: 18 Years – 46 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemia-reperfusion Injury

Interventions

Type	Name	Description
DRUG	heme arginate administration	heme arginate 1 mg/kg body weight 24 hours prior to ischemia
DRUG	Placebo administration	NaCl isotonic

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2011-10-28
• Last updated: 2011-10-28

Locations

1 site across 1 country: Austria