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

NCT00417378 | Completed Phase 4 DMC

• 1 other identifier: Impella M22
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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).

Conditions

Shock, Cardiogenic; Myocardial Infarction

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

• Cardiac index

  within 1 hour after device implantation

Secondary Outcomes (3)

• Hemodynamic and metabolic parameters

  until to hospital discharge

• Mortality

  within 30 and 180 days

• device-related complications:hemolysis and major bleedings

  during hospitalization

Study Arms (2)

1

ACTIVE COMPARATOR

Intraaortic balloon counterpulsation (IABP)

Device: Intraaortic Balloon Pump

2

EXPERIMENTAL

Left Ventricular Assist Device (Impella LP2.5)

Device: Left Ventricular Assist Device Impella LP 2.5

Interventions

Left Ventricular Assist Device Impella LP 2.5 DEVICE

Left Ventricular Assist Device

2

Intraaortic Balloon Pump DEVICE

Counterpulsation

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Abiomed Inc.: collaborator

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (4)

• Hochman JS, Sleeper LA, Webb JG, Dzavik V, Buller CE, Aylward P, Col J, White HD; SHOCK Investigators. Early revascularization and long-term survival in cardiogenic shock complicating acute myocardial infarction. JAMA. 2006 Jun 7;295(21):2511-5. doi: 10.1001/jama.295.21.2511.

  PMID: 16757723 BACKGROUND

• Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.

  PMID: 10460813 BACKGROUND

• Ryan TJ, Antman EM, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel B, Russell RO, Smith EE 3rd, Weaver WD, Gibbons RJ, Alpert JS, Eagle KA, Gardner TJ, Garson A Jr, Gregoratos G, Ryan TJ, Smith SC Jr. 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1999 Sep;34(3):890-911. doi: 10.1016/s0735-1097(99)00351-4. No abstract available.

  PMID: 10483976 BACKGROUND

• Seyfarth M, Sibbing D, Bauer I, Frohlich G, Bott-Flugel L, Byrne R, Dirschinger J, Kastrati A, Schomig A. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.1016/j.jacc.2008.05.065.

  PMID: 19007597 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Melchior Seyfarth, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Josef Dirschinger, MD

  1. Medizinische Klinik, Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2006
• First Posted: January 1, 2007
• Study Start: August 1, 2004
• Study Completion: March 1, 2006
• Last Updated: November 28, 2007

Record last verified: 2007-11

Locations

DE (2)