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Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock (IABPSHOCK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469248
First Posted: May 4, 2007
Last Update Posted: May 4, 2007
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.
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
  Purpose
The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.

Condition Intervention
Myocardial Infarction Cardiogenic Shock Device: Intra-aortic balloon pump counterpulsation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-Aortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock - The Prospective, Randomised IABP SHOCK Trial for Attenuation of Multi-Organ Dysfunction Syndrome

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • APACHE II SCORE [ Time Frame: 4 days ]

Secondary Outcome Measures:
  • Haemodynamic state [ Time Frame: 4 days ]
  • BNP levels [ Time Frame: 4 days ]
  • Inflammatory activation [ Time Frame: 4 days ]
  • Mortality [ Time Frame: 4 days ]

Enrollment: 45
Study Start Date: March 2003
Study Completion Date: June 2004
Detailed Description:

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) with cardiogenic shock (CS) are often treated with Intra-aortic balloon pump counterpulsation (IABP) although the evidence to support this is limited. We conducted a prospective, randomised clinical trial, of IABP as an addition to PCI centred therapy, in patients with AMI complicated by CS.

45 patients with AMI and CS undergoing PCI were randomised to care with or without IABP. Over 4 days, APACHE II scores, haemodynamic parameters, inflammatory markers and BNP levels were collected to assess the impact of IABP treatment on CS triggered multi organ dysfunction syndrome (MODS).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion Criteria:

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469248


Locations
Germany
Department of Medicine III, Klinikum Krollwitz, Martin Luther University
Halle (Saale), Saxony - Anhalt, Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Study Chair: Michael Buerke, MD Martin Luther University
Principal Investigator: Roland Prondzinsky, MD Martin Luther University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Prondzinsky R, Unverzagt S, Lemm H, Wegener N, Heinroth K, Buerke U, Fiedler M, Thiery J, Haerting J, Werdan K, Buerke M. Acute myocardial infarction and cardiogenic shock: prognostic impact of cytokines: INF-γ, TNF-α, MIP-1β, G-CSF, and MCP-1β. Med Klin Intensivmed Notfmed. 2012 Sep;107(6):476-84. Epub 2012 Jul 20.
Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, Buerke U, Raaz U, Ebelt H, Schlitt A, Heinroth K, Haerting J, Werdan K, Buerke M. Hemodynamic effects of intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP shock trial. Shock. 2012 Apr;37(4):378-84. doi: 10.1097/SHK.0b013e31824a67af.
Prondzinsky R, Unverzagt S, Lemm H, Wegener NA, Schlitt A, Heinroth KM, Dietz S, Buerke U, Kellner P, Loppnow H, Fiedler MG, Thiery J, Werdan K, Buerke M. Interleukin-6, -7, -8 and -10 predict outcome in acute myocardial infarction complicated by cardiogenic shock. Clin Res Cardiol. 2012 May;101(5):375-84. doi: 10.1007/s00392-011-0403-3. Epub 2012 Jan 3.
Prondzinsky R, Lemm H, Swyter M, Wegener N, Unverzagt S, Carter JM, Russ M, Schlitt A, Buerke U, Christoph A, Schmidt H, Winkler M, Thiery J, Werdan K, Buerke M. Intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP SHOCK Trial for attenuation of multiorgan dysfunction syndrome. Crit Care Med. 2010 Jan;38(1):152-60. doi: 10.1097/CCM.0b013e3181b78671.

ClinicalTrials.gov Identifier: NCT00469248     History of Changes
Other Study ID Numbers: MLU-IABPSHOCK
First Submitted: May 3, 2007
First Posted: May 4, 2007
Last Update Posted: May 4, 2007
Last Verified: April 2007

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
Myocardial infarction
Cardiogenic shock
Systemic inflammatory response syndrome
Percutaneous coronary intervention
aortic balloon counterpulsation

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases


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