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临床试验/NCT02816385
NCT02816385已完成不适用

Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia

Brugmann University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Contractility index of the right ventricle

研究概览

简要总结

Myocardial protection is a fundamental element for the safety of patients when performing cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical practice to protect the myocardium when performing aortic clamp.

Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled perfusate). The composition of the cardioplegic solutions and their method of administration continuously changed over the years.

At the present date, cold blood cardioplegias are performed in the investigator's center. The investigators regularly use two modes of administration: either by an antegrade path (injection in the coronary arteries), or a retrograde one (injection in the venous system). At present, there are no elements supporting the superiority or inferiority of one path compared to another. The difficulty lies within a clear estimation of the contractility state of the ventricular cardiac muscle.

Technological developments in recent years provided a solution to this problem. The analysis of the pressure/volume curves generated by a ventricle allows an accurate quantification of the myocardial contractility. This requires the use of conductance catheters to accurately measure the ventricular volume and the ventricular pressure. The absolute ventricular contractility is then deduced with the help of a software.

The investigators intend to use this pressure-volume loops, obtained with conductance catheters, to compare the contractility of the right heart ventricle after antegrade vs retrograde cardioplegia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Need for myocardial revascularisation
  • Normal FEVG ( > 50%)

排除标准

  • Valvulopathy
  • Associated procedures

研究组 & 干预措施

Antegrade Cardioplegia

Active Comparator

Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

干预措施: Antegrade cardioplegia (Procedure)

Retrograde Cardioplegia

Experimental

Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

干预措施: Retrograde cardioplegia (Procedure)

结局指标

主要结局

Contractility index of the right ventricle

时间窗: 20 minutes after discontinuation of the extracorporeal blood circulation

Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, 20 minutes after discontinuation of the extracorporeal circulation, with absence of inotropic support.

次要结局

  • Troponin post operative level(24h post surgery)

研究者

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

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (2)

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