EUCTR2006-002940-28-NL进行中（未招募）不适用
HEBE III: A prospective, randomised, double blind, placebo controlled clinical study to examine the effects of a single bolus erythropoietin on left ventricular function in patients with an acute myocardial infarction - HEBE III
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ICI
- 入组人数
- 400
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
- •Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
- •a.chest pain suggestive for acute myocardial infarction
- •b.symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia
- •c.ECG with ST-T segment elevation > 1 mV in 2 or more leads
- •d.TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;
- •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
- •a.Hemoglobin levels > 10.6 mmol/L;
- •b.Anticipated additional revascularisation within 4 months;
- •c.Cardiogenic shock;
- •d.Presence of other serious medical conditions
- •e.Pregnancy/breast feeding
- •f.Malignant hypertension
- •g.End stage renal failure (kreatinin > 220 ?mol/l)
- •h.Previous treatment with rh-EPO
- •i.Blood transfusion <12 weeks prior to randomisation
- •j.Allergy against rh-EPO
- •k.Polycytemia verae
- •l.Previous acute myocardial infarction
- •m.Concomitant inflammatory or malignant disease
- •n.Recent trauma or major surgery
- •o.Unwilling to sign informed consent
- •p.contra-indications for MRI (pacemaker and other metal subjects)
研究者
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