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临床试验/NCT00791206
NCT00791206Unknown2 期

Single Blind Randomized Controlled Crossover Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia

The Hospital for Sick Children0 个研究点目标入组 20 人开始时间: 2008年11月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
20
主要终点
Improvement of endothelial and microvascular dysfunction induced by 20 minutes of forearm ischemia.

研究概览

简要总结

Previously, the preconditioning signaling pathways have been studied on molecular level or in animal model. By using MR spectroscopy and imaging in a dynamic human model of preconditioning, we will have a better understanding how mitochondrial and endothelial function are affected by preconditioning in-vivo.

详细描述

Ischemic preconditioning is a mechanism that protects tissue against ischemia-reperfusion injury. The protective effect of preconditioning is induced by short periods (1-5 minutes) of non-lethal ischemia to the target tissue, which becomes resistant to a prolonged, otherwise lethal, period of ischemia. Despite its proven potency in experimental models, ischemic preconditioning has not reached widespread clinical application because of the difficulties in applying the stimulus to the target organ (eg Heart, Brain), and even brief ischemia to the target organ can cause dysfunction.

Remote ischemic preconditioning (RIPC) is a more clinically relevant stimulus. It has been shown that preconditioning of one coronary territory induces ischemia protection in other parts of the heart. Subsequently, other studies have shown, in rodent models, that preconditioning of one organ (eg kidney) could induce protection in other organs (eg heart). We recently have confirmed, in a series of animal and human preclinical studies, that this concept can be widened; ultimately showing that four 5-minute episodes of ischemia to the skeletal limb muscles (induced by inflating a standard blood pressure cuff to a level higher than the blood pressure) protects the heart and lungs against ischemia-reperfusion injury in children undergoing cardiac surgery using cardiopulmonary bypass.

The current research is designed to investigate with MRI spectroscopy techonology, the potential physiological mechanisms involved in the protective effects of preconditioning, and the effects of ischemia and exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy male and female volunteers
  • •Post-pubescent non-athletes between the ages of >16 and <40 years of age.

排除标准

  • •Older than 40 year old.
  • •Younger than 16 year old.
  • •Major medical condition
  • •Illness, surgery or medical intervention in the last 48 hours.
  • •Diabetes Mellitus
  • •Caffeine intake in the last 48 hours
  • •Athlete (more than 5 training sessions per week)

研究组 & 干预措施

2

Other

干预措施: Sham preconditioning (Procedure)

1

Experimental

干预措施: Real preconditioning (Procedure)

结局指标

主要结局

Improvement of endothelial and microvascular dysfunction induced by 20 minutes of forearm ischemia.

时间窗: 1 hour

Improvement in mitochondrial function following the preconditioning as evidenced by a faster rate of recovery of phosphocreatinine after exercise.

时间窗: 2 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Redington

Head, Heart Centre-Cardiology Division

The Hospital for Sick Children

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