Counterpulsation Reduces Infarct Size Pre-PCI for AMI
- Conditions
- Acute Myocardial Infarction (AMI)
- Registration Number
- NCT00833612
- Lead Sponsor
- Datascope Corp.
- Brief Summary
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
- Detailed Description
Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 339
- Able to understand and sign an ICF
- ≥ 18 and ≤ 90 years of age
- General good health, in the opinion of the investigator
- ST elevation of 2mm in 2 contiguous anterior leads or ≥ 4mm total in anterior leads
- Scheduled for PCI < 6 hours from onset of symptoms of MI
- Known contraindication to MRI
- Prior thrombolytic therapy during the index event
- Known history of MI
- Known severe aortic insufficiency
- Known aortic aneurysm
- Known severe calcific aorta-iliac disease or peripheral vascular disease
- Experiencing cardiac shock
- Known end-stage renal disease
- Weight >400 lbs. or height <4 ft.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. 3-5 days
- Secondary Outcome Measures
Name Time Method To determine the effect of IABC before mechanical reperfusion on post PCI cardiovascular function and major adverse cardiac events (MACE) (ie, death, reinfarction, and CHF) at 30 days and 6 months. 30 days and 6 months post randomization
Trial Locations
- Locations (40)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Essentia Institute of Rural Health (St Mary's)
🇺🇸Duluth, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Newark Beth Israel Hospital
🇺🇸Newark, New Jersey, United States
Scroll for more (30 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States