Counterpulsation to Reduce Infarct Size pre-percutaneous coronary intervention (pre-PCI) for Acute Myocardial Infarctio

Completed

Conditions: Acute myocardial infarction
Circulatory System

Registration Number: ISRCTN89012474

Lead Sponsor: Datascope Corp. (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

To be eligible for this study, a subject must meet all of the following criteria:
1. Able to understand and sign an informed consent form (ICF)
2. Greater than or equal to 18 and less than or equal to 90 years of age, either sex
3. General good health, in the opinion of the investigator
4. ST elevation of greater than or equal to 2 mm in two contiguous anterior leads or greater than or equal to 4 mm total in anterior leads
5. Scheduled for PCI less than 6 hours from onset of symptoms of anterior MI

Exclusion Criteria

A subject who meets any of the following exclusion criteria will not be enrolled in the study:
1. Known contraindication to magnetic resonance imaging (MRI)
2. Prior thrombolytic therapy during the index event
3. Known history of MI
4. Prior coronary artery bypass graft surgery
5. Known severe aortic insufficiency
6. Known aortic aneurysm
7. Known severe calcific aorta-iliac disease or peripheral vascular disease
8. Experiencing cardiogenic shock
9. Known end-stage renal disease
10. Weight greater than 400 lbs or height less than 4 feet
11. Women of childbearing potential

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Infarct size measured by MRI at 3 to 5 days post-PCI or at discharge, whichever comes first. The primary analysis population will be restricted to the subgroup of subjects with nondistal left anterior descending (LAD) lesion and thrombolysis in myocardial infarction (TIMI) flow of 0 or 1. <br>2. Other efficacy endpoints of importance: <br>2.1. Left ventricular ejection fraction (LVEF)<br>2.2. Microvascular obstruction (MVO) by MRI <br>2.3. Electrocardiogram (ECG) ST-segment resolution 90 minutes post-PCI <br>2.4. Left ventricular end-diastolic volume (LVEDV)<br>2.5. Left ventricular end-systolic volume (LVESV)<br>2.6. Salvage index by MRI

Secondary Outcome Measures

Name	Time	Method
1. Vascular complications, defined as major limb ischaemia requiring operative intervention in the affected IAB limb after removal of the IAB <br>2. Amputation <br>3. Major bleed per GUSTO I definition, i.e., intracranial haemorrhage or bleeding that causes haemodynamic compromise and requires intervention <br>4. Major adverse cardiac events (MACE) within 24 hours of hospital admission, including: <br>4.1. Ventricular arrhythmias: VT, VF <br>4.2. Severe hypotension: systolic blood pressure (SBP) less than 90 mmHg for more than or equal to 5 minutes, requiring inotropic/pressor support medications or IV fluid <br>4.3. Cardiac arrest