Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock (IABPSHOCK)

This study has been completed.
Information provided by:
Martin-Luther-Universität Halle-Wittenberg Identifier:
First received: May 3, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

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:

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).


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion Criteria:

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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

Additional publications automatically indexed to this study by Identifier (NCT Number): 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, Cardiogenic
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on November 25, 2014