A multi-centre, randomised controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size pre-percutaneous coronary intervention (pre-PCI) for acute myocardial infarction

Datascope Corp. (USA)0 个研究点目标入组 300 人开始时间: 2008年12月10日最近更新: 2015年1月13日

适应症

试验速览

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•To be eligible for this study, a subject must meet all of the following criteria:
•1. Able to understand and sign an informed consent form (ICF)
•2. Greater than or equal to 18 and less than or equal to 90 years of age, either sex
•3. General good health, in the opinion of the investigator
•4. ST elevation of greater than or equal to 2 mm in two contiguous anterior leads or greater than or equal to 4 mm total in anterior leads
•5. Scheduled for PCI less than 6 hours from onset of symptoms of anterior MI

•A subject who meets any of the following exclusion criteria will not be enrolled in the study:
•1. Known contraindication to magnetic resonance imaging (MRI)
•2. Prior thrombolytic therapy during the index event
•3. Known history of MI
•4. Prior coronary artery bypass graft surgery
•5. Known severe aortic insufficiency
•6. Known aortic aneurysm
•7. Known severe calcific aorta-iliac disease or peripheral vascular disease
•8. Experiencing cardiogenic shock
•9. Known end-stage renal disease
•10. Weight greater than 400 lbs or height less than 4 feet
•11. Women of childbearing potential

发起方

Datascope Corp. (USA)