Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00491036
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2007-06-22
Brief Title:
Intraaortic Balloon Pump in Cardiogenic Shock II
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
Randomized Clinical Study of Intraaortic Balloon Pump Use in Cardiogenic Shock Complicating Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IABP-SHOCK II
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None