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 number | NCT00833612 |
| Secondary identifying numbers | 00001 |
- 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
Scientific
Duke University Medical Centre
Box 3126 Medical Centre
Durham, North Carolina
27710
United States of America
Study information
| Study design | Multi-centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | CRISP-AMI |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2009 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Belgium
- France
- Germany
- Ireland
- Italy
- United Kingdom
- United States of America
Study participating centre
Duke University Medical Centre
Durham, North Carolina
27710
United States of America
27710
United States of America
Sponsor information
Datascope Corp. (USA)
Industry
Industry
c/o Debra Joseph
15 Law Drive
Fairfield, New Jersey
07004
United States of America
| Website | http://www.datascope.com |
|---|---|
"ROR" |
https://ror.org/05pwp0t27 |
Funders
Funder type
Industry
Datascope Corp. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
