Clinical trial NCT00833612: Counterpulsation Reduces Infarct Size Pre-PCI for 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction (AMI)
Keywords: IABC
AMI
Lead sponsor: Datascope Corp.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Flinders Medical Centre
First posted: 2009-02-02
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
timeFrame: 3-5 days
Secondary outcomes:
measure: 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.
timeFrame: 30 days and 6 months post randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Duluth
country: United States
facility: Essentia Institute of Rural Health (St Mary's)
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Hospital
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center-Strong Memorial Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Hasselt
country: Belgium
facility: Virga Jesse
city: Massy Cedex
country: France
facility: Institut Hospitalier Jacques Cartier
state: Alsace
city: Dresden
country: Germany
facility: Klinik fur Innere Medizin und Kardiologie
city: Freiburg
country: Germany
facility: University of Freiburg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Hyderabad
country: India
facility: Gurunanak CARE Hospital
state: Andhra Pradesh
city: Vadodara
country: India
facility: Baroda Heart Institute and Research Centre
state: Gujrat
city: Bangalore
country: India
facility: Saint John's Medical College and Hospital
state: Karnataka
city: Bangalore
country: India
facility: Bhagwan Mahaveer Jain Heart Centre
city: Bangalore
country: India
facility: Apollo Hospitals
city: Delhi
country: India
facility: Medanta - The Medicity
city: Hyderabad
country: India
facility: CARE Hospital
city: Jalandhar
country: India
facility: Tagore Hospital and Heart Care Centre
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
city: New Delhi
country: India
facility: Sir Gangaram Hospital
city: West Bengal
country: India
facility: Apollo Gleneagles Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Cargeei
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Dorset
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St. Thomas Hospital
Study officials:
affiliation: Duke University
name: Magnus Ohman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.