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Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00417378
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : November 28, 2007
Sponsor:
Collaborator:
Abiomed Inc.
Information provided by:
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date  ICMJE December 29, 2006
First Posted Date  ICMJE January 1, 2007
Last Update Posted Date November 28, 2007
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2007)
Cardiac index [ Time Frame: within 1 hour after device implantation ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2006)
Hemodynamic improvement within 1 hour after device implantation (cardiac index)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2007)
  • Hemodynamic and metabolic parameters [ Time Frame: until to hospital discharge ]
  • Mortality [ Time Frame: within 30 and 180 days ]
  • device-related complications:hemolysis and major bleedings [ Time Frame: during hospitalization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2006)
  • Hemodynamic and metabolic parameters at longer follow-up
  • mortality at 30 days and 6 months
  • device-related complications:hemolysis and major bleedings
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)
Official Title  ICMJE Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes
Brief Summary The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).
Detailed Description

Cardiogenic shock due to a left ventricular failure after myocardial infarction (MI) is associated with a mortality rate of 50-70 % despite all efforts such as immediate PCI of the occluded vessel, positive inotropic drugs, and the use of intraaortic balloon counterpulsation (IABP). While urgent heart transplantation or the surgical implantation of high-volume left ventricular assist devices are possible treatment options, a widespread use of these techniques for this common complication of myocardial infarction is limited. Because of the easy, percutaneous use of an intraaortic balloon pump, IABP is the method of choice for mechanical assistance in these patients. Despite a lack of randomized data, the ACC/AHA guidelines recommend the use of an intraaortic balloon counterpulsation (Level of evidence IB) in patients with a cardiogenic shock after myocardial infarction. However, improvement of the hemodynamic state by the use of an IABP is limited and the lack of an active cardiac support remains the major limitation of this treatment. Percutaneous left ventricular assist devices may both overcome the limitation of a surgical approach and offer the potential benefit of an active cardiac support during recovery of the failing left ventricle after PCI.

Previous studies have demonstrated a significant improvement of hemodynamic parameters by the use of a catheter-based miniaturized rotary blood pump (Impella LP2.5, Abiomed-Impella CardioSystems GmbH, Aachen, Germany), that is placed retrogradely through the aortic valve. The microaxial pump aspirates blood from the left ventricle and expels it to the ascending aorta with a maximal flow of 2.5 L/min. Randomized data comparing the LVAD with IABP are missing. Therefore, this trial will primarily compare the hemodynamic improvement of the LVAD (Impella LP2.5) with the hemodynamic improvement of an intraaortic balloon counterpulsation (IABP), while secondarily feasibility, safety and mortality will be compared.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Shock, Cardiogenic
  • Myocardial Infarction
Intervention  ICMJE
  • Device: Left Ventricular Assist Device Impella LP 2.5
    Left Ventricular Assist Device
  • Device: Intraaortic Balloon Pump
    Counterpulsation
Study Arms  ICMJE
  • Active Comparator: 1
    Intraaortic balloon counterpulsation (IABP)
    Intervention: Device: Intraaortic Balloon Pump
  • Experimental: 2
    Left Ventricular Assist Device (Impella LP2.5)
    Intervention: Device: Left Ventricular Assist Device Impella LP 2.5
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2006)
26
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute coronary syndrome (ACS/AMI) < 48h and cardiogenic shock defined as:

    • Clinical criteria: Hypotension (syst.BP < 90 mmHg and HR > 90/min or an AV- Block II-III) or the need for positive inotropic drugs to maintain BB > 90mm Hg)and end-organ hypoperfusion
    • Hemodynamic criteria: CI < 2.2 L/min/qm and a PCWP > 15 mmHg or an EF of LV < 30% and LVEDP > 20 mmHg.
  • Written informed consent of the patient or his/hers relatives

Exclusion Criteria:

  • Age < 18 years
  • Prolonged Resuscitation (> 30min)
  • Hypertrophic Obstructive Cardiomyopathy
  • Thrombus in left ventricle
  • Treatment with IABP
  • Severe valvular disease or mechanical heart valve
  • Cardiogenic Shock due to mechanical complications of myocardial infarction such as VSD, acute mitral regurgitation >II°, rupture of the ventricle
  • Failure of the right ventricle defined as the need for a RV Assist Device
  • Septic condition
  • Cerebral Disease
  • Bleeding with a need for surgical intervention
  • Pulmonary embolism
  • Allergy to Heparin or any known coagulopathy
  • Aortic regurgitation >II°
  • Pregnancy
  • Inclusion in another study or trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00417378
Other Study ID Numbers  ICMJE Impella M22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE Abiomed Inc.
Investigators  ICMJE
Study Chair: Melchior Seyfarth, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Josef Dirschinger, MD 1. Medizinische Klinik, Klinikum rechts der Isar
PRS Account Deutsches Herzzentrum Muenchen
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP