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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN89012474
• Date of registration: 10/12/2008
• Primary sponsor: Datascope Corp. (USA)
• Public title: Counterpulsation to Reduce Infarct Size pre-percutaneous coronary intervention (pre-PCI) for Acute Myocardial Infarction CRISP-AMI
• Scientific title: A multi-centre, randomised controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size pre-percutaneous coronary intervention (pre-PCI) for acute myocardial infarction
• Date of first enrolment: Jan 1 2009
• Target sample size: 300
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN89012474
• Study type: Interventional
• Study design: Multi-centre, randomised controlled trial

Countries of recruitment

Belgium, France, Germany, Ireland, Italy, United Kingdom

Contacts

• Name: Magnus Ohman

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Acute myocardial infarction

Intervention(s)

Patients will be randomised to recieve an intra-aortic balloon prior to primary percutaneous coronary intervention. The control group will be those patients randomised not to receive an intra-aortic balloon prior to their primary percutaneous coronary intervention.

For subjects randomised to receive IABC, the balloon will be removed on the day following the procedure if the subject is haemodynamically stable. Twenty-four to 48 hours is the optimal length of time for the subject to use the balloon, with a minimum time of 12 hours. All patients will be followed up at 3 months and 6 months.

Primary Outcome(s)

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.
2. Other efficacy endpoints of importance:
2.1. Left ventricular ejection fraction (LVEF)
2.2. Microvascular obstruction (MVO) by MRI
2.3. Electrocardiogram (ECG) ST-segment resolution 90 minutes post-PCI
2.4. Left ventricular end-diastolic volume (LVEDV)
2.5. Left ventricular end-systolic volume (LVESV)
2.6. Salvage index by MRI

Secondary Outcome(s)

1. Vascular complications, defined as major limb ischaemia requiring operative intervention in the affected IAB limb after removal of the IAB
2. Amputation
3. Major bleed per GUSTO I definition, i.e., intracranial haemorrhage or bleeding that causes haemodynamic compromise and requires intervention
4. Major adverse cardiac events (MACE) within 24 hours of hospital admission, including:
4.1. Ventricular arrhythmias: VT, VF
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
4.3. Cardiac arrest

Secondary ID(s)

00001

NCT00833612

Source(s) of Monetary Support

Datascope Corp. (USA)

Secondary Sponsor(s)

N/A