Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock (IABPSHOCK)

May 3, 2007 updated by: Martin-Luther-Universität Halle-Wittenberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony - Anhalt
      • Halle (Saale), Saxony - Anhalt, Germany, 06120
        • Department of Medicine III, Klinikum Krollwitz, Martin Luther University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion Criteria:

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
APACHE II SCORE
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Haemodynamic state
Time Frame: 4 days
4 days
BNP levels
Time Frame: 4 days
4 days
Inflammatory activation
Time Frame: 4 days
4 days
Mortality
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • Study Chair: Michael Buerke, MD, Martin Luther University
  • Principal Investigator: Roland Prondzinsky, MD, Martin Luther University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

May 4, 2007

Last Update Submitted That Met QC Criteria

May 3, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLU-IABPSHOCK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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