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临床试验/NCT03022877
NCT03022877撤回不适用

Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions

RWTH Aachen University0 个研究点开始时间: 2017年6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
撤回
主要终点
Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi)

研究概览

简要总结

In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

详细描述

An acute ST-elevation myocardial infarction (STEMI) is a severe disease that triggers an adverse remodeling, and served in progressive heart failure with a case fatality rate of 50% in 5 years. The opening of the occluded vessel is the first and most important therapy, the reperfusion improved both the function as well as the long-term survival. At the same time, experimental and clinical studies show, however, that this reperfusion self-reinforced damage of the myocardium. An additional Intervention in this trigger phase could not only reduce the acute damage, but long-term protective effects. Both effects could be an approach for the Calcium-Sensitizer Levosimendan in the animal model. So far, no clear effect on the remodeling and survive was demonstrated after myocardial infarction in the clinic. This could be mainly due to the delayed application in relation to the reperfusion and on the selection of suitable methods for the presentation of the effects on myocardial structure and function. In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • STEMI of the anterior wall < 6 hrs
  • capacity to Consent

排除标准

  • previous myocardial infarction or bypass surgery
  • relevant vitium
  • STEMI of the posterior wall
  • any contraindications to MRI
  • unstable hemodynamics (hypotension, catecholamine therapy, severe arrhythmia), -respiratory failure
  • onset of symptoms more than 6 hours.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo is given as a Bolus (instead of Bolus application of Levosimendan) over 10 min i.v., starting 10 min before recanalization.

干预措施: Levosimendan (Drug)

Bolus Levosimendan

Active Comparator

Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization.

干预措施: Levosimendan (Drug)

Bolus and infusion Levosimendan

Active Comparator

Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization and additionally as continuous infusion (0.1-0.2 µg/kg/min i. v. for 24 hours).

干预措施: Levosimendan (Drug)

结局指标

主要结局

Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi)

时间窗: 12 months after coronary intervention due to the infarction

echocardiography and MRI examinations (LVEDVi) and comparison between baseline and 12 months data

次要结局

  • structural changes(12 months after coronary intervention due to the infarction)
  • functional changes (spirometry)(12 months after coronary intervention due to the infarction)
  • Event-free survival(12 months after coronary intervention due to the infarction)
  • Size of the acute myocardial damage due to the infarction(12 months after coronary intervention due to the infarction)
  • functional changes (imaging)(12 months after coronary intervention due to the infarction)

研究者

申办方类型
Other
责任方
Sponsor

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