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Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock (IABPSHOCK)

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ClinicalTrials.gov Identifier: NCT00469248
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : May 4, 2007
Information provided by:
Martin-Luther-Universität Halle-Wittenberg

Brief Summary:
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 or disease Intervention/treatment
Myocardial Infarction Cardiogenic Shock Device: Intra-aortic balloon pump counterpulsation

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : March 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. Haemodynamic state [ Time Frame: 4 days ]
  2. BNP levels [ Time Frame: 4 days ]
  3. Inflammatory activation [ Time Frame: 4 days ]
  4. Mortality [ Time Frame: 4 days ]

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

Inclusion Criteria:

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion Criteria:

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction

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

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

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
First Posted: May 4, 2007    Key Record Dates
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:
Myocardial Infarction
Shock, Cardiogenic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases