The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
研究概览
简要总结
Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles.
A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 18 and 45 years
- •Nonsmoker for more than 3 months
- •Body mass index between 18 and 25 kg/m2
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
- •Treatment in the previous 3 weeks with any drug including over-the-counter drugs
- •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
结局指标
主要结局
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
时间窗: during and 30 min after ischemia
Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
时间窗: during and 30 minutes after ischemia
Serum markers of myocellular injury (myoglobin, creatine-kinase)
时间窗: prior to, directly and 24 hours after ischemia
次要结局
未报告次要终点