The Effects of Intravenous Heme Arginate on Functional Magnetic Resonance Imaging During Ischemia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- BOLD MRI signal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
干预措施: Placebo administration (Drug)
Heme arginate treatment
干预措施: heme arginate administration (Drug)
结局指标
主要结局
BOLD MRI signal
时间窗: 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
时间窗: 24 hours after ischemia
(myoglobin, creatine-kinase)
次要结局
- Blood pressure(20 minutes prior to and 40 minutes after ischemia)
- Heart rate(prior to and after ischemia)
研究者
MWolzt
Prof. Dr. Michael Wolzt
Medical University of Vienna