Counterpulsation Reduces Infarct Size Pre-PCI for AMI

Acute Myocardial Infarction (AMI) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833612
• Other study ID #: P00001
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2009
• Last updated: June 24, 2011
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Datascope Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction (AMI)
• Infarction
• Myocardial Infarction

Intervention

Device:
• Counterpulsation with IAB
IABC pre-reperfusion PCI

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park
Belgium	Virga Jesse	Hasselt
France	Institut Hospitalier Jacques Cartier	Massy Cedex	Alsace
Germany	Klinik fur Innere Medizin und Kardiologie	Dresden
Germany	University of Freiburg	Freiburg
Germany	Herzzentrum Leipzig GmbH	Leipzig
India	Apollo Hospitals	Bangalore
India	Bhagwan Mahaveer Jain Heart Centre	Bangalore
India	Saint John's Medical College and Hospital	Bangalore	Karnataka
India	Medanta - The Medicity	Delhi
India	CARE Hospital	Hyderabad
India	Gurunanak CARE Hospital	Hyderabad	Andhra Pradesh
India	Tagore Hospital and Heart Care Centre	Jalandhar
India	Indraprastha Apollo Hospital	New Delhi
India	Sir Gangaram Hospital	New Delhi
India	Baroda Heart Institute and Research Centre	Vadodara	Gujrat
India	Apollo Gleneagles Hospital	West Bengal
Ireland	Mater Misericordiae University Hospital	Dublin
Italy	Azienda Ospedaliero Universitaria Cargeei	Firenze
Netherlands	Catharina Hospital	Eindhoven
United Kingdom	Royal Bournemouth Hospital	Dorset
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	St. Thomas Hospital	London
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Essentia Institute of Rural Health (St Mary's)	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Southern California	Los Angeles	California
United States	Newark Beth Israel Hospital	Newark	New Jersey
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center-Strong Memorial Hospital	Rochester	New York
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Datascope Corp.	Duke University, Flinders Medical Centre

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  India,  Ireland,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.		3-5 days	No
Secondary	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.		30 days and 6 months post randomization	No