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

Datascope

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction (AMI)

Treatments: Device: Counterpulsation with IAB

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00833612

P00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 339 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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339 participants in 1 patient group

Control arm of study

No Intervention group

Treatment:

Device: Counterpulsation with IAB