NL-OMON40846撤回3 期
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack (RESUS-AMI) - RESUS-AMI
niversity college Cork, Centre for Research in Vascular Biology Bio Sciences Institute0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
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 (ECG) 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 PCI for STEMI
- •5. LVEF during PCI < 40%
- •6. TIMI flow grade 3 in IRA following reperfusion and stenting
排除标准
- •4.3 EXCLUSION CRITERIA
- •Subjects having any of the following criteria will not be enrolled in the study:
- •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 (SBP<80mm Hg requiring pressors or IABP)
- •6. Estimated glomerular filtration rate (eGFR) < 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 (e.g. pacemaker, implanted cardiac defibrillator or other magnetically activated device, aneurysm clips, claustrophobia)
- •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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