NL-OMON30616招募中3 期
HEBE III: A prospective, randomised, 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 466
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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;
排除标准
- •a. Hemoglobin levels > 10.6 mmol/L;
- •b. Anticipated additional revascularisation within 6 weeks;
- •c. Cardiogenic shock;
- •d. Presence of other serious medical conditions
- •e. Pregnancy/breast feeding
- •f. Malignant hypertension
- •g. End stage renal failure (kreatinin > 220 micromol/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. Atrium fibrillation
研究者
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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 IIIPatients with a successful primary PCI (TIMI 2/3) for a first acute myocardial infarctionEUCTR2006-002940-28-NLICI400
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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.One group will receive the study medication and the other group will receive placebo medication.NL-OMON26840Inter Cardiological Institute NetherlandsVan Buchem Stichting (UMCG)400
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