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临床试验/NCT02993484
NCT02993484已完成不适用

The Role of Mitochondrial Respiration in the Cardioprotective Capacity of IPC in Diabetic and Non-diabetic Patients

University of Aarhus0 个研究点目标入组 39 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
39
主要终点
Mitochondrial respiration of individual complexes

研究概览

简要总结

The overall aim of this study is to examine the role of mitochondrial respiration in human diabetic tissue before and after ischemia. Furthermore we will examine the ability of ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic performance of both non-diabetic and diabetic fibers after ischemia. To increase our understanding on the metabolic changes during ischemia in both non-diabetic and diabetic tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic mitochondrial respiration.

详细描述

20 diabetic and 20 non-diabetic patients undergoing elective CABG surgery or other heart surgery where extracorporal circulation is used will be included in the study. The patiens will not be given any treatment prior to the operation. During the cardiac surgery a small sample of the heart is routinely removed when the patient is connection to the heart-lung machine. From this tissue sample it is possible to isolate muscle trabeculae which will be used in an atrial strip model and randomized to one of four types of treatment. Simultaneously with the isolation of the trabeculae, a fifth trabecular will be used to assess mitochondrial respiration at baseline. Group 1 will serve as a sham control, group 2 will serve as ischemic control and receive an extended period of hypoxia, Group 3 will be treated with ischemic preconditioning, where short periods of non lethal lack of oxygen will be given directly to the tissue (after removal from the patient) prior to the extended period of hypoxia, Group 4 will receive dimethyl malonate prior to the prolonged hypoxia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing CABG or other surgery where extracorporal circulation will be used.

排除标准

  • raise in ischemic markers within 4 weeks
  • ejection fraction <30
  • Atrial fibrilation
  • Oral opioid treatment

研究组 & 干预措施

non-diabetic Sham control

Experimental

Heart tissue obtained from non-diabetic patients undergoing surgery will not receive drugs or ischemia

干预措施: Sham (Other)

non-diabetic Ischemia reperfusion

Experimental

Heart tissue from non-diabetic patients undergoing surgery will not receive drugs but will receive ischemia

干预措施: Ischemia reperfusion (Other)

non-diabetic Ischemic preconditioning

Experimental

Heart tissue from non-diabetic patients undergoing surgery will not receive drugs but will receive short periods of ischemia prior to index ischemia

干预措施: Ischemic preconditioning (Biological)

non-diabetic Dimethyl malonate

Experimental

Heart tissue from non-diabetic patients undergoing surgery will receive a drug (Dimethyl Malonate) prior to index ischemia

干预措施: Dimethyl Malonate (Drug)

Diabetic Sham control

Experimental

Heart tissue obtained from diabetic patients undergoing surgery will not receive drugs or ischemia

干预措施: Sham (Other)

Diabetic Ischemia reperfusion

Experimental

Heart tissue from diabetic patients undergoing surgery will not receive drugs but will receive ischemia

干预措施: Ischemia reperfusion (Other)

Diabetic Ischemic preconditioning

Experimental

Heart tissue from diabetic patients undergoing surgery will not receive drugs but will receive short periods of ischemia prior to index ischemia

干预措施: Ischemic preconditioning (Biological)

Diabetic Dimethyl malonate

Experimental

Heart tissue from diabetic patients undergoing surgery will receive a drug (Dimethyl Malonate) prior to index ischemia

干预措施: Dimethyl Malonate (Drug)

结局指标

主要结局

Mitochondrial respiration of individual complexes

时间窗: Outcome will be assessed within a year when the inclusion of patients is complete

Mitochondrial respiration of individual complexes will serve as primary outcome and will be examined by oxygraph technique.

次要结局

  • Hemodynamic performance(Outcome will be assessed within a year when the inclusion of patients is complete)

研究者

申办方类型
Other
责任方
Sponsor

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