Counterpulsation Reduces Infarct Size Pre-PCI for AMI
- Conditions
- Acute Myocardial Infarction (AMI)
- Interventions
- Device: Counterpulsation with IAB
- 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
- Arm && Interventions
Group Intervention Description Control arm of study Counterpulsation with IAB -
- 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)
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Institut Hospitalier Jacques Cartier
🇫🇷Massy Cedex, Alsace, France
Gurunanak CARE Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Sir Gangaram Hospital
🇮🇳New Delhi, India
Apollo Gleneagles Hospital
🇮🇳West Bengal, India
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Azienda Ospedaliero Universitaria Cargeei
🇮🇹Firenze, Italy
CARE Hospital
🇮🇳Hyderabad, India
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, 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
Newark Beth Israel Hospital
🇺🇸Newark, New Jersey, United States
University of Rochester Medical Center-Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Flinders Medical Centre
🇦🇺Bedford Park, Australia
Virga Jesse
🇧🇪Hasselt, Belgium
University of Freiburg
🇩🇪Freiburg, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Klinik fur Innere Medizin und Kardiologie
🇩🇪Dresden, Germany
Saint John's Medical College and Hospital
🇮🇳Bangalore, Karnataka, India
Bhagwan Mahaveer Jain Heart Centre
🇮🇳Bangalore, India
Baroda Heart Institute and Research Centre
🇮🇳Vadodara, Gujrat, India
Apollo Hospitals
🇮🇳Bangalore, India
Medanta - The Medicity
🇮🇳Delhi, India
Tagore Hospital and Heart Care Centre
🇮🇳Jalandhar, India
Indraprastha Apollo Hospital
🇮🇳New Delhi, India
Royal Bournemouth Hospital
🇬🇧Dorset, United Kingdom
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
St. Thomas Hospital
🇬🇧London, United Kingdom
University of Southern California
🇺🇸Los Angeles, California, United States