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Completed

NCT Number: NCT00833612

Counterpulsation Reduces Infarct Size Pre-PCI for AMI

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

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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Flinders Medical Centre, Bedford Park, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Counterpulsation with IAB

Device

IABC pre-reperfusion PCI

Other names: CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F

Primary outcomes

  1. To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.

    Time frame: 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.

    Time frame: 30 days and 6 months post randomization

Sponsors and collaborators

Lead sponsor

Datascope Corp.

Industry

Collaborators

  • Duke University
  • Flinders Medical Centre

Registry information

Official study 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

Acronym: CRISP-AMI

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2009
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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