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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00833612
Ethics application status
Date submitted
27/01/2009
Date registered
30/01/2009
Date last updated
24/06/2011

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
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/show/NCT00833612
Trial related presentations / publications
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
Other publications