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

ISRCTN ISRCTN89012474
DOI https://doi.org/10.1186/ISRCTN89012474
ClinicalTrials.gov (NCT) NCT00833612
Protocol serial number 00001
Sponsor Datascope Corp. (USA)
Funder Datascope Corp. (USA)
Submission date
05/12/2008
Registration date
10/12/2008
Last edited
28/08/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Magnus Ohman
Scientific

Duke University Medical Centre
Box 3126 Medical Centre
Durham, North Carolina
27710
United States of America

Study information

Primary study designInterventional
Study designMulti-centre, randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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
Study acronymCRISP-AMI
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute myocardial infarction
InterventionPatients 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 typeOther
Primary outcome measure(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

Key secondary outcome measure(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

Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit90 Years
SexAll
Target sample size at registration300
Key inclusion criteriaTo 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
Key exclusion criteriaA 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
Date of first enrolment01/01/2009
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • United Kingdom
  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • United States of America

Study participating centre

Duke University Medical Centre
Durham, North Carolina
27710
United States of America

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 28/09/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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