Counterpulsation Reduces Infarct Size Pre-PCI for AMI (CRISP-AMI)

This study has been completed.
Duke University
Flinders Medical Centre
Information provided by:
Datascope Corp. Identifier:
First received: January 27, 2009
Last updated: June 24, 2011
Last verified: June 2011

Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

Condition Intervention Phase
Acute Myocardial Infarction (AMI)
Device: Counterpulsation with IAB
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Datascope Corp.:

Primary Outcome Measures:
  • To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 days and 6 months post randomization ] [ Designated as safety issue: No ]

Enrollment: 339
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control arm of study Device: Counterpulsation with IAB
IABC pre-reperfusion PCI
Other Name: CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F

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.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00833612

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Sponsors and Collaborators
Datascope Corp.
Duke University
Flinders Medical Centre
Principal Investigator: Magnus Ohman, MD Duke University
  More Information

No publications provided by Datascope Corp.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Debra Joseph/VP Marketing and Clinical Services, Datascope Corp. Identifier: NCT00833612     History of Changes
Other Study ID Numbers: P00001
Study First Received: January 27, 2009
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Datascope Corp.:

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on April 17, 2014