跳至主要内容
临床试验/NL-OMON26840
NL-OMON26840尚未招募不适用

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.

Inter Cardiological Institute NetherlandsVan Buchem Stichting (UMCG)0 个研究点目标入组 400 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400

研究概览

简要总结

/A

研究设计

研究类型
Interventional

入排标准

入选标准

  • Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
  • 1. Chest pain suggestive for acute myocardial infarction;
  • 2. Symptom onset < 12 hour after hospital admission, or < 24 hour in case ongoing ischemia;
  • 3. ECG with ST-T segment elevation > 1 mV in 2 or more leads;
  • 4. TIMI flow 0/1 before primary PCI on diagnostic coronary angiography.

排除标准

  • 1. Hemoglobin levels > 10.6 mmol/L;
  • 2. Anticipated additional revascularisation within 4 months;
  • 3. Cardiogenic shock;
  • 4. Presence of other serious medical conditions;
  • 5. Pregnancy/breast feeding;
  • 6. Malignant hypertension;
  • 7. End stage renal failure (kreatinin > 220 micromol/l);
  • 8. Previous treatment with rh-EPO;
  • 9. Blood transfusion <12 weeks prior to randomisation;
  • 10. Allergy against rh-EPO;
  • 11. Polycytemia verae;
  • 12. Previous acute myocardial infarction;
  • 13. Concomitant inflammatory or malignant disease;
  • 14. Recent trauma or major surgery;
  • 15. Unwilling to sign informed consent;
  • 16. Contra-indications for MRI (pacemaker and other metal subjects).

研究者

发起方
Inter Cardiological Institute NetherlandsVan Buchem Stichting (UMCG)

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