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

This study has been completed.
Sponsor:
Collaborators:
Duke University
Flinders Medical Centre
Information provided by:
Datascope Corp.
ClinicalTrials.gov Identifier:
NCT00833612
First received: January 27, 2009
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  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
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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Datascope Corp.

Additional 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
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.:
IABC
AMI

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

ClinicalTrials.gov processed this record on May 19, 2013