EUCTR2004-002732-25-NO进行中（未招募）不适用
Safety and efficacy of levosimendan in patients with acute myocardial infarction complicated by symptomatic left ventricular failure
Geir Øystein Andersen, Department of Cardiology, Ulleval University Hospital0 个研究点开始时间: 2005年9月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients who are hospitalised with acute ST-segment elevation myocardial infarction (STEMI: ECG definition) subjected to acute PCI
- •patients with non-ST segment elevation myocardial infarction subjected to PCI within 72 hours after start of chest pain.
- •and all of the following (1-3)
- •oRevascularization by PCI with opening of an occluded coronary artery or balloon dilatation of a stenotic coronary artery presumed to be culprit lesion.
- •oLeft-ventricular ejection fraction (EF) must be less than 40% measured by echocardiography.
- •oDyspnoea at rest at screening and at least one of the following signs of left ventricular failure:
- •Pulmonary edema
- •Signs of marked pulmonary congestion on chest x-ray
- •Need for continuous-elevated positive airway-pressure ventilation (CPAP) or mechanical ventilation
- •Need for IV diuretics.
- •Oliguria (<0.5 ml/kg/hour) as a sign of hypoperfusion of the kidneys after volume therapy.
- •Subgroup of patients with cardiogenic shock:
- •A prospectively defined subgroup included by stratified randomisation.
- •Additional inclusion criteria includes both of the following:
- •oSystolic BP <90 mmHg after 60 min of adequate volume therapy or systolic BP between 90 and 100 mmHg with inotropic support by catecholamine infusion
- •oSigns of hypoperfusion (low-output heart failure)
- •Oliguria (diuresis <0.5 ml/kg/hour)
- •Cold, clammy extremities
- •Reduced consciousness
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •oAge below 20 years,
- •oHeart rate above 120 bpm
- •oSeptic shock
- •oCreatinine >450 µmol/l
- •oHepatic impairment
- •oSignificant mechanical outlet obstruction
- •oAllergy against study drug medication or one of its ingredients
- •oAnaemia (Hb < 8 g/dl)
研究者
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