EUCTR2011-000480-27-IE进行中（未招募）1 期
A Randomised Trial Evaluating the Safety and Efficacy of a Single Low Dose of Intracoronary Insulin-like Growth Factor-1 Following Percutaneous Coronary Intervention for ST-Elevation Acute Myocardial Infarction (RESUS-AMI) - RESUS-AMI
niversity College Cork0 个研究点目标入组 51 人开始时间: 2011年4月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
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
- •1. Age 18 – 75
- •2. Subject presents to hospital within 2-12 hours of the onset of myocardial ischemic pain of at least 30 minutes duration
- •3. Twelve-lead electrocardiogram reveals one of the following: ST-segment elevation * 0.1 mV in two or more limb leads, or * 0.2 mV in two or more contiguous precordial leads indicative of acute myocardial infarction, or left bundle-branch block
- •4. Undergoing percutaneous coronary intervention (PCI) for ST elevation myocardial infarction
- •5. Left ventricular ejection fraction during PCI < or = 40%
- •6. TIMI flow grade 3 in infarct related artery following reperfusion and stenting
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. History of prior myocardial infarction
- •2. Prior history of heart failure, left ventricular dysfunction or cardiomyopathy
- •3. Active or suspected neoplasia
- •4. Known impaired liver function
- •5. Cardiogenic shock
- •6. Estimated glomerular filtration rate < 45 ml/min/1.73m2
- •7. History of hypoglycaemia requiring hospitalisation
- •8. History of primary insulin growth factor-1 deficiency or growth hormone disorders including acromegaly
- •9. Contraindication to cardiac MRI
- •10. Pregnancy (for women of childbearing potential, have a negative pregnancy test at screening) or nursing mothers
- •11. Known allergy to study drug or any of its inactive ingredients
- •12. Treatment with another investigational agent within 30 days of enrolment
- •13. Subjects unable or unwilling to comply with follow-up requirements of study
- •14. Subjects unable to provide written informed consent
研究者
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