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Clinical Trials/NCT00469248
NCT00469248
Completed
N/A

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

Martin-Luther-Universität Halle-Wittenberg1 site in 1 country45 target enrollmentMarch 2003

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Enrollment
45
Locations
1
Primary Endpoint
APACHE II SCORE
Status
Completed
Last Updated
19 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
June 2004
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Acute myocardial infarction
  • Cardiogenic shock

Exclusion Criteria

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction

Outcomes

Primary Outcomes

APACHE II SCORE

Time Frame: 4 days

Secondary Outcomes

  • Haemodynamic state(4 days)
  • BNP levels(4 days)
  • Inflammatory activation(4 days)
  • Mortality(4 days)

Study Sites (1)

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