Counterpulsation Reduces Infarct Size Pre-PCI for AMI
CRISP-AMI
A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
1 other identifier
interventional
339
10 countries
40
Brief Summary
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Typical duration for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
February 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 27, 2011
June 1, 2011
2.2 years
January 27, 2009
June 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
3-5 days
Secondary Outcomes (1)
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
Study Arms (1)
Control arm of study
NO INTERVENTIONInterventions
IABC pre-reperfusion PCI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Datascope Corp.lead
- Duke Universitycollaborator
- Flinders Medical Centrecollaborator
Study Sites (40)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Southern California
Los Angeles, California, 90033, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Essentia Institute of Rural Health (St Mary's)
Duluth, Minnesota, 55805, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103, United States
Newark Beth Israel Hospital
Newark, New Jersey, 07112, United States
University of Rochester Medical Center-Strong Memorial Hospital
Rochester, New York, 14627, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17603, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Flinders Medical Centre
Bedford Park, 5042, Australia
Virga Jesse
Hasselt, 3500, Belgium
Institut Hospitalier Jacques Cartier
Massy, Alsace, 91349, France
Klinik fur Innere Medizin und Kardiologie
Dresden, 1307, Germany
University of Freiburg
Freiburg im Breisgau, Germany
Herzzentrum Leipzig GmbH
Leipzig, D-04289, Germany
Gurunanak CARE Hospital
Hyderabad, Andhra Pradesh, 500020, India
Baroda Heart Institute and Research Centre
Vadodara, Gujarat, 390 007, India
Saint John's Medical College and Hospital
Bangalore, Karnataka, 560034, India
Bhagwan Mahaveer Jain Heart Centre
Bangalore, 560052, India
Apollo Hospitals
Bangalore, India
Medanta - The Medicity
Delhi, 122 001, India
CARE Hospital
Hyderabad, 50034, India
Tagore Hospital and Heart Care Centre
Jalandhar, 144 008, India
Indraprastha Apollo Hospital
New Delhi, 110044, India
Sir Gangaram Hospital
New Delhi, 110060, India
Apollo Gleneagles Hospital
West Bengal, India
Mater Misericordiae University Hospital
Dublin, 7, Ireland
Azienda Ospedaliero Universitaria Cargeei
Florence, 50141, Italy
Catharina Hospital
Eindhoven, 2, Netherlands
Royal Bournemouth Hospital
Dorset, BH7 7DW, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH8 9RS, United Kingdom
Leeds General Infirmary
Leeds, LS9 7TF, United Kingdom
St. Thomas Hospital
London, SE1 7EH, United Kingdom
Related Publications (2)
Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA. 2011 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.
PMID: 21878431DERIVEDPatel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.
PMID: 21742089DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Ohman, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 27, 2009
First Posted
February 2, 2009
Study Start
December 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06