NCT00469248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
Last Updated

May 4, 2007

Status Verified

April 1, 2007

First QC Date

May 3, 2007

Last Update Submit

May 3, 2007

Conditions

Myocardial InfarctionCardiogenic Shock

Keywords

Myocardial infarctionCardiogenic shockSystemic inflammatory response syndromePercutaneous coronary interventionaortic balloon counterpulsation

Outcome Measures

Primary Outcomes (1)

  • APACHE II SCORE

    4 days

Secondary Outcomes (4)

  • Haemodynamic state

    4 days

  • BNP levels

    4 days

  • Inflammatory activation

    4 days

  • Mortality

    4 days

Interventions

Intra-aortic balloon pump counterpulsationDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction
  • Cardiogenic shock

You may not qualify if:

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine III, Klinikum Krollwitz, Martin Luther University

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Publications (4)

  • 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.

    PMID: 22810435DERIVED

  • 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.

    PMID: 22266974DERIVED

  • 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.

    PMID: 22212516DERIVED

  • 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.

    PMID: 19770739DERIVED

MeSH Terms

Conditions

Myocardial InfarctionShock, CardiogenicSystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockInflammation

Study Officials

  • Michael Buerke, MD

    Martin Luther University

    STUDY CHAIR

  • Roland Prondzinsky, MD

    Martin Luther University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

March 1, 2003

Study Completion

June 1, 2004

Last Updated

May 4, 2007

Record last verified: 2007-04

Locations

DE(1)