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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

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Trial Conditions
  • Acute Myocardial Infarction (AMI)
What is the purpose of this trial?

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

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 90 

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Magnus Ohman, MD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Device
  • Counterpulsation with IAB
Physician Researcher

Investigator Name:

  • Magnus Ohman, MD

Other Information

Sponsor: Datascope Corp.
Phase: Phase 4
Trial ID: NCT00833612
Volunteers:  Not Accepting Healthy Volunteers

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