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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
May 3, 2007
May 4, 2007
May 4, 2007
March 2003
Not Provided
APACHE II SCORE [ Time Frame: 4 days ]
Same as current
No Changes Posted
  • Haemodynamic state [ Time Frame: 4 days ]
  • BNP levels [ Time Frame: 4 days ]
  • Inflammatory activation [ Time Frame: 4 days ]
  • Mortality [ Time Frame: 4 days ]
Same as current
Not Provided
Not Provided
 
Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock
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
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Cardiogenic Shock
Device: Intra-aortic balloon pump counterpulsation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2004
Not Provided

Inclusion Criteria:

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion Criteria:

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00469248
MLU-IABPSHOCK
No
Not Provided
Not Provided
Not Provided
Martin-Luther-Universität Halle-Wittenberg
Not Provided
Study Chair: Michael Buerke, MD Martin Luther University
Principal Investigator: Roland Prondzinsky, MD Martin Luther University
Martin-Luther-Universität Halle-Wittenberg
April 2007

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