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Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock

NCT ID: NCT00469248

Last Updated: 2007-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Myocardial Infarction Cardiogenic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Intra-aortic balloon pump counterpulsation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Acute myocardial infarction
* Cardiogenic shock

Exclusion Criteria

* Absent peripheral pulses
* Mechanical complications of myocardial infarction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Principal Investigators

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Michael Buerke, MD

Role: STUDY_CHAIR

Martin Luther University

Roland Prondzinsky, MD

Role: PRINCIPAL_INVESTIGATOR

Martin Luther University

Locations

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Department of Medicine III, Klinikum Krollwitz, Martin Luther University

Halle, Saxony-Anhalt, Germany

Site Status

Countries

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Germany

References

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Prondzinsky R, Unverzagt S, Lemm H, Wegener N, Heinroth K, Buerke U, Fiedler M, Thiery J, Haerting J, Werdan K, Buerke M. Acute myocardial infarction and cardiogenic shock: prognostic impact of cytokines: INF-gamma, TNF-alpha, MIP-1beta, G-CSF, and MCP-1beta. Med Klin Intensivmed Notfmed. 2012 Sep;107(6):476-84. doi: 10.1007/s00063-012-0117-y. Epub 2012 Jul 20.

Reference Type DERIVED
PMID: 22810435 (View on PubMed)

Prondzinsky R, Unverzagt S, Russ M, Lemm H, Swyter M, Wegener N, Buerke U, Raaz U, Ebelt H, Schlitt A, Heinroth K, Haerting J, Werdan K, Buerke M. Hemodynamic effects of intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP shock trial. Shock. 2012 Apr;37(4):378-84. doi: 10.1097/SHK.0b013e31824a67af.

Reference Type DERIVED
PMID: 22266974 (View on PubMed)

Prondzinsky R, Unverzagt S, Lemm H, Wegener NA, Schlitt A, Heinroth KM, Dietz S, Buerke U, Kellner P, Loppnow H, Fiedler MG, Thiery J, Werdan K, Buerke M. Interleukin-6, -7, -8 and -10 predict outcome in acute myocardial infarction complicated by cardiogenic shock. Clin Res Cardiol. 2012 May;101(5):375-84. doi: 10.1007/s00392-011-0403-3. Epub 2012 Jan 3.

Reference Type DERIVED
PMID: 22212516 (View on PubMed)

Prondzinsky R, Lemm H, Swyter M, Wegener N, Unverzagt S, Carter JM, Russ M, Schlitt A, Buerke U, Christoph A, Schmidt H, Winkler M, Thiery J, Werdan K, Buerke M. Intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP SHOCK Trial for attenuation of multiorgan dysfunction syndrome. Crit Care Med. 2010 Jan;38(1):152-60. doi: 10.1097/CCM.0b013e3181b78671.

Reference Type DERIVED
PMID: 19770739 (View on PubMed)

Other Identifiers

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MLU-IABPSHOCK

Identifier Type: -

Identifier Source: org_study_id