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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes

Conditions
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Shock, Cardiogenic, Myocardial Infarction

Intervention / Treatment
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* Device: Left Ventricular Assist Device Impella LP 2.5
* Device: Intraaortic Balloon Pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intraaortic balloon counterpulsation (IABP) | Device: Intraaortic Balloon Pump<br>* Counterpulsation<br>|
| Experimental: 2<br>Left Ventricular Assist Device (Impella LP2.5) | Device: Left Ventricular Assist Device Impella LP 2.5<br>* Left Ventricular Assist Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index |  | within 1 hour after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic and metabolic parameters |  | until to hospital discharge | 
| Mortality |  | within 30 and 180 days | 
| device-related complications:hemolysis and major bleedings |  | during hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS