Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock (IABPSHOCK)
Primary Purpose
Myocardial Infarction, Cardiogenic Shock
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intra-aortic balloon pump counterpulsation
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Cardiogenic shock, Systemic inflammatory response syndrome, Percutaneous coronary intervention, aortic balloon counterpulsation
Eligibility Criteria
Inclusion Criteria:
- Acute myocardial infarction
- Cardiogenic shock
Exclusion Criteria:
- Absent peripheral pulses
- Mechanical complications of myocardial infarction
Sites / Locations
- Department of Medicine III, Klinikum Krollwitz, Martin Luther University
Outcomes
Primary Outcome Measures
APACHE II SCORE
Secondary Outcome Measures
Haemodynamic state
BNP levels
Inflammatory activation
Mortality
Full Information
NCT ID
NCT00469248
First Posted
May 3, 2007
Last Updated
May 3, 2007
Sponsor
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT00469248
Brief Title
Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock
Acronym
IABPSHOCK
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Cardiogenic Shock
Keywords
Myocardial infarction, Cardiogenic shock, Systemic inflammatory response syndrome, Percutaneous coronary intervention, aortic balloon counterpulsation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Intra-aortic balloon pump counterpulsation
Primary Outcome Measure Information:
Title
APACHE II SCORE
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Haemodynamic state
Time Frame
4 days
Title
BNP levels
Time Frame
4 days
Title
Inflammatory activation
Time Frame
4 days
Title
Mortality
Time Frame
4 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute myocardial infarction
Cardiogenic shock
Exclusion Criteria:
Absent peripheral pulses
Mechanical complications of myocardial infarction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Buerke, MD
Organizational Affiliation
Martin Luther University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roland Prondzinsky, MD
Organizational Affiliation
Martin Luther University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine III, Klinikum Krollwitz, Martin Luther University
City
Halle (Saale)
State/Province
Saxony - Anhalt
ZIP/Postal Code
06120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22810435
Citation
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.
Results Reference
derived
PubMed Identifier
22266974
Citation
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.
Results Reference
derived
PubMed Identifier
22212516
Citation
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.
Results Reference
derived
PubMed Identifier
19770739
Citation
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.
Results Reference
derived
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Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock
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