Aortic Balloon Counterpulastion in Myocardial Infarction Related Shock

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469248
• Other study ID #: MLU-IABPSHOCK
• Status: Completed
• Phase: N/A
• First received: May 3, 2007
• Last updated: May 3, 2007
• Start date: March 2003
• Est. completion date: June 2004

Study information

• Verified date: April 2007
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute myocardial infarction

• Cardiogenic shock

Exclusion Criteria:

• Absent peripheral pulses

• Mechanical complications of myocardial infarction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiogenic Shock
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Device:
• Intra-aortic balloon pump counterpulsation

Locations

Country	Name	City	State
Germany	Department of Medicine III, Klinikum Krollwitz, Martin Luther University	Halle (Saale)	Saxony - Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	APACHE II SCORE		4 days
Secondary	Haemodynamic state		4 days
Secondary	BNP levels		4 days
Secondary	Inflammatory activation		4 days
Secondary	Mortality		4 days