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Counterpulsation Reduces Infarct Size Pre-PCI for AMI (CRISP-AMI)

Primary Purpose

Acute Myocardial Infarction (AMI)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Counterpulsation with IAB
Sponsored by
Datascope Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction (AMI) focused on measuring IABC, AMI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Southern California
  • Washington Hospital Center
  • Cleveland Clinic Florida
  • Tufts Medical Center
  • Caritas St. Elizabeth's Medical Center
  • Essentia Institute of Rural Health (St Mary's)
  • University of Nebraska Medical Center
  • University of Medicine and Dentistry of New Jersey
  • Newark Beth Israel Hospital
  • University of Rochester Medical Center-Strong Memorial Hospital
  • Duke University Medical Center
  • Lancaster General Hospital
  • Temple University Hospital
  • Allegheny General Hospital
  • University of Texas Health Science Center at Houston
  • Flinders Medical Centre
  • Virga Jesse
  • Institut Hospitalier Jacques Cartier
  • Klinik fur Innere Medizin und Kardiologie
  • University of Freiburg
  • Herzzentrum Leipzig GmbH
  • Gurunanak CARE Hospital
  • Baroda Heart Institute and Research Centre
  • Saint John's Medical College and Hospital
  • Bhagwan Mahaveer Jain Heart Centre
  • Apollo Hospitals
  • Medanta - The Medicity
  • CARE Hospital
  • Tagore Hospital and Heart Care Centre
  • Indraprastha Apollo Hospital
  • Sir Gangaram Hospital
  • Apollo Gleneagles Hospital
  • Mater Misericordiae University Hospital
  • Azienda Ospedaliero Universitaria Cargeei
  • Catharina Hospital
  • Royal Bournemouth Hospital
  • Royal Infirmary of Edinburgh
  • Leeds General Infirmary
  • St. Thomas Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Control arm of study

Arm Description

Outcomes

Primary Outcome Measures

To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.

Secondary Outcome Measures

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.

Full Information

First Posted
January 27, 2009
Last Updated
June 24, 2011
Sponsor
Datascope Corp.
Collaborators
Duke University, Flinders Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00833612
Brief Title
Counterpulsation Reduces Infarct Size Pre-PCI for AMI
Acronym
CRISP-AMI
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Datascope Corp.
Collaborators
Duke University, Flinders Medical Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
Detailed Description
Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction (AMI)
Keywords
IABC, AMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm of study
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Counterpulsation with IAB
Other Intervention Name(s)
CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F
Intervention Description
IABC pre-reperfusion PCI
Primary Outcome Measure Information:
Title
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
Time Frame
3-5 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
30 days and 6 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Ohman, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Essentia Institute of Rural Health (St Mary's)
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Newark Beth Israel Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of Rochester Medical Center-Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy Cedex
State/Province
Alsace
ZIP/Postal Code
91349
Country
France
Facility Name
Klinik fur Innere Medizin und Kardiologie
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
University of Freiburg
City
Freiburg
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
D-04289
Country
Germany
Facility Name
Gurunanak CARE Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500020
Country
India
Facility Name
Baroda Heart Institute and Research Centre
City
Vadodara
State/Province
Gujrat
ZIP/Postal Code
390 007
Country
India
Facility Name
Saint John's Medical College and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Bhagwan Mahaveer Jain Heart Centre
City
Bangalore
ZIP/Postal Code
560052
Country
India
Facility Name
Apollo Hospitals
City
Bangalore
Country
India
Facility Name
Medanta - The Medicity
City
Delhi
ZIP/Postal Code
122 001
Country
India
Facility Name
CARE Hospital
City
Hyderabad
ZIP/Postal Code
50034
Country
India
Facility Name
Tagore Hospital and Heart Care Centre
City
Jalandhar
ZIP/Postal Code
144 008
Country
India
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
ZIP/Postal Code
110044
Country
India
Facility Name
Sir Gangaram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Apollo Gleneagles Hospital
City
West Bengal
Country
India
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Azienda Ospedaliero Universitaria Cargeei
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
2
Country
Netherlands
Facility Name
Royal Bournemouth Hospital
City
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH8 9RS
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St. Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21878431
Citation
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.
Results Reference
derived
PubMed Identifier
21742089
Citation
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.
Results Reference
derived

Learn more about this trial

Counterpulsation Reduces Infarct Size Pre-PCI for AMI

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