Acute Myocardial Infarction (AMI)
Conditions
Keywords
IABC, AMI
Brief summary
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
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.
Interventions
DEVICECounterpulsation with IAB
IABC pre-reperfusion PCI
Sponsors
Duke University
Flinders Medical Centre
Datascope Corp.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. | 3-5 days |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 30 days and 6 months post randomization |
Countries
Australia, Belgium, France, Germany, India, Ireland, Italy, Netherlands, United Kingdom, United States
Outcome results
None listed