Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock - Full Text View

Sponsored by:	Martin-Luther-Universität Halle-Wittenberg
Information provided by:	Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:	NCT00469248

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

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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, Saxony - Anhalt
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

Study ID Numbers:	MLU-IABPSHOCK
Study First Received:	May 3, 2007
Last Updated:	May 3, 2007
ClinicalTrials.gov Identifier:	NCT00469248
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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Necrosis
Heart Diseases
Shock
Shock, Cardiogenic

Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009