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Trial record 8 of 47 for:    cardiogenic shock
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Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock (IABPSHOCK)

This study has been completed.
Sponsor:
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00469248
First received: May 3, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Heart Attack Shock
U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Martin-Luther-Universität Halle-Wittenberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00469248     History of Changes
Other Study ID Numbers: MLU-IABPSHOCK
Study First Received: May 3, 2007
Last Updated: May 3, 2007
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013