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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833612
First Posted: February 2, 2009
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Duke University
Flinders Medical Centre
Information provided by:
Datascope Corp.
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833612


  Show 40 Study Locations
Sponsors and Collaborators
Datascope Corp.
Duke University
Flinders Medical Centre
Investigators
Principal Investigator: Magnus Ohman, MD Duke University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Debra Joseph/VP Marketing and Clinical Services, Datascope Corp.
ClinicalTrials.gov Identifier: NCT00833612     History of Changes
Other Study ID Numbers: P00001
First Submitted: January 27, 2009
First Posted: February 2, 2009
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Datascope Corp.:
IABC
AMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases