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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00833612




Registration number
NCT00833612
Ethics application status
Date submitted
27/01/2009
Date registered
2/02/2009
Date last updated
27/06/2011

Titles & IDs
Public title
Counterpulsation Reduces Infarct Size Pre-PCI for AMI
Scientific title
A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
Secondary ID [1] 0 0
P00001
Universal Trial Number (UTN)
Trial acronym
CRISP-AMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction (AMI) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Counterpulsation with IAB

No intervention: Control arm of study -


Treatment: Devices: Counterpulsation with IAB
IABC pre-reperfusion PCI
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
Timepoint [1] 0 0
3-5 days
Secondary outcome [1] 0 0
To determine the effect of IABC before mechanical reperfusion on post PCI cardiovascular function and major adverse cardiac events (MACE) (ie, death, reinfarction, and CHF) at 30 days and 6 months.
Timepoint [1] 0 0
30 days and 6 months post randomization

Eligibility
Key inclusion criteria
* Able to understand and sign an ICF
* = 18 and = 90 years of age
* General good health, in the opinion of the investigator
* ST elevation of 2mm in 2 contiguous anterior leads or = 4mm total in anterior leads
* Scheduled for PCI < 6 hours from onset of symptoms of MI
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known contraindication to MRI
* Prior thrombolytic therapy during the index event
* Known history of MI
* Known severe aortic insufficiency
* Known aortic aneurysm
* Known severe calcific aorta-iliac disease or peripheral vascular disease
* Experiencing cardiac shock
* Known end-stage renal disease
* Weight >400 lbs. or height <4 ft.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
339
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Belgium
State/province [13] 0 0
Hasselt
Country [14] 0 0
France
State/province [14] 0 0
Alsace
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Leipzig
Country [18] 0 0
India
State/province [18] 0 0
Andhra Pradesh
Country [19] 0 0
India
State/province [19] 0 0
Gujrat
Country [20] 0 0
India
State/province [20] 0 0
Karnataka
Country [21] 0 0
India
State/province [21] 0 0
Bangalore
Country [22] 0 0
India
State/province [22] 0 0
Delhi
Country [23] 0 0
India
State/province [23] 0 0
Hyderabad
Country [24] 0 0
India
State/province [24] 0 0
Jalandhar
Country [25] 0 0
India
State/province [25] 0 0
New Delhi
Country [26] 0 0
India
State/province [26] 0 0
West Bengal
Country [27] 0 0
Ireland
State/province [27] 0 0
Dublin
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Netherlands
State/province [29] 0 0
Eindhoven
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Dorset
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Edinburgh
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Leeds
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Datascope Corp.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Duke University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Flinders Medical Centre
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
Trial website
https://clinicaltrials.gov/study/NCT00833612
Trial related presentations / publications
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 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.
Patel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.
Public notes

Contacts
Principal investigator
Name 0 0
Magnus Ohman, MD
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00833612