EUCTR2004-005259-32-GB进行中（未招募）不适用
A phase 2 randomised trial to investigate the effects of recombinant human erythropoietin on infarct size in patients undergoing primary percutaneous coronary angiography for ST-segment elevation myocardial infarction. - Erythropoietin in acute MI
Imperial College Heathcare NHS Trust0 个研究点开始时间: 2005年11月7日最近更新:
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
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
- •=18 years of age
- •Weight between = 50 kg and =120 kg
- •Suspected of having his/her first-documented STEMI
- •Symptoms of ischemia of = 20 min with = 6h prior to PCI
- •=1mm ST elevation in at least two contiguous limb leads or = 2mm
- •ST elevation in 2 contiguous chest leads
- •Primary PCI to occur within 6h from the onset of symptoms
- •Women of childbearing potential must have a negative pregnancy test
- •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
- •History or ECG evidence of previous STEMI
- •Cardiogenic shock
- •NYHA class III-IV heart failure
- •LBBB or AF on electrocardiogram
- •Major trauma, major surgery, eye, spinal cord, or brain surgery within the last 3 months
- •History of advanced liver disease
- •History of chronic renal impairment (creatinine >200µmol/L)
- •History of stroke
- •Pregnancy or breast-feeding
- •Dependence on alcohol or other drugs of abuse
- •Significant psychiatric/neurological disease that might prevent adherence to the requirements of the protocol
- •Current treatment with human recombinant erythropoietin
- •Current haemodialysis or peritoneal dialysis
- •History of malignancy including haematological and other solid tissue tumours
- •History of primary or secondary polycythaemia
- •Inability to read the patient information sheet
- •History of pulmonary embolism or deep vein thrombosis
- •History of critical limb ischaemia
- •Patients with poorly controlled hypertension (systolic BP>180, diastolic BP>100mmHg)
研究者
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