Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00833612
Protocol/serial number
00001
Study information
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
Acronym
CRISP-AMI
Study hypothesis
The purpose of this study is to examine whether the use of an intra-aortic balloon (IAB) pump is beneficial for patients having a heart attack before the angioplasty procedure. Subjects with anterior acute ST-segment elevation myocardial infarction (STEMI) who receive an IAB before primary percutaneous coronary intervention (PCI) will have decreased anterior myocardial infarction (MI) size.
Ethics approval
Not provided at time of registration
Study design
Multi-centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute myocardial infarction
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/01/2009
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Belgium, France, Germany, Ireland, Italy, United Kingdom
Trial participating centre
Duke University Medical Centre
Durham, North Carolina
27710
United States of America
Sponsor information
Organisation
Datascope Corp. (USA)
Sponsor details
c/o Debra Joseph
15 Law Drive
Fairfield
New Jersey
07004
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Datascope Corp. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21878431
Publication citations
-
Results
Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM, Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial., JAMA, 2011, 306, 12, 1329-1337, doi: 10.1001/jama.2011.1280.