NCT00491036

Intraaortic Balloon Pump in Cardiogenic Shock II

Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration. The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.

Conditions

• Myocardial Infarction
• Shock, Cardiogenic

Interventions

Type	Name	Description
DEVICE	Intraaortic balloon pump	intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-06-01
• Completion: 2016-10-01
• First posted: 2007-06-25
• Last updated: 2017-05-02

Locations

20 sites across 1 country: Germany