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

June 24, 2011 updated by: Datascope Corp.

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

Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
  • Belgium
      • Hasselt, Belgium, 3500
        • Virga Jesse
  • France
    • Alsace
      • Massy Cedex, Alsace, France, 91349
        • Institut Hospitalier Jacques Cartier
  • Germany
      • Dresden, Germany, 1307
        • Klinik fur Innere Medizin und Kardiologie
      • Freiburg, Germany
        • University of Freiburg
      • Leipzig, Germany, D-04289
        • Herzzentrum Leipzig GmbH
  • India
      • Bangalore, India, 560052
        • Bhagwan Mahaveer Jain Heart Centre
      • Bangalore, India
        • Apollo Hospitals
      • Delhi, India, 122 001
        • Medanta - The Medicity
      • Hyderabad, India, 50034
        • Care hospital
      • Jalandhar, India, 144 008
        • Tagore Hospital and Heart Care Centre
      • New Delhi, India, 110060
        • Sir Gangaram Hospital
      • New Delhi, India, 110044
        • Indraprastha Apollo Hospital
      • West Bengal, India
        • Apollo Gleneagles Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500020
        • Gurunanak CARE Hospital
    • Gujrat
      • Vadodara, Gujrat, India, 390 007
        • Baroda Heart Institute and Research Centre
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Saint John's Medical College and Hospital
  • Ireland
      • Dublin, Ireland, 7
        • Mater Misericordiae University Hospital
  • Italy
      • Firenze, Italy, 50141
        • Azienda Ospedaliero Universitaria Cargeei
  • Netherlands
      • Eindhoven, Netherlands, 2
        • Catharina Hospital
  • United Kingdom
      • Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Edinburgh, United Kingdom, EH8 9RS
        • Royal Infirmary of Edinburgh
      • Leeds, United Kingdom, LS9 7TF
        • Leeds General Infirmary
      • London, United Kingdom, SE1 7EH
        • St. Thomas Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Institute of Rural Health (St Mary's)
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Hospital
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersey
    • New York
      • Rochester, New York, United States, 14627
        • University of Rochester Medical Center-Strong Memorial Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17603
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm of study
Device: Counterpulsation with IAB
IABC pre-reperfusion PCI
Other Names:
  • CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
Time Frame: 3-5 days
3-5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days and 6 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Datascope Corp.

Collaborators

Duke University
Flinders Medical Centre

Investigators

  • Principal Investigator: Magnus Ohman, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction (AMI)

Clinical Trials on Counterpulsation with IAB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe