Status:
COMPLETED
Counterpulsation Reduces Infarct Size Pre-PCI for AMI
Lead Sponsor:
Datascope Corp.
Collaborating Sponsors:
Duke University
Flinders Medical Centre
Conditions:
Acute Myocardial Infarction (AMI)
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 foll...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT00833612
Start Date
December 1 2008
End Date
March 1 2011
Last Update
June 27 2011
Active Locations (40)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Southern California
Los Angeles, California, United States, 90033
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Cleveland Clinic Florida
Weston, Florida, United States, 33331