Condition category
Circulatory System
Date applied
05/12/2008
Date assigned
10/12/2008
Last edited
28/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Magnus Ohman

ORCID ID

Contact details

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

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 measures

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

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

http://www.datascope.com

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21878431

Publication citations

  1. 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.

Additional files

Editorial Notes