A Phase 4 interventional study of Intraaortic balloon pump in Myocardial Infarction and Shock, Cardiogenic, sponsored by University of Leipzig. Completed at 20 sites in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-05-02.
Sponsored by University of Leipzig · Phase 4, Interventional, and Treatment
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 600 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with
Signs of impaired organ perfusion with at least one of the following:
Exclusion criteria:
Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab
Device: Intraaortic balloon pump
Patients in cardiogenic shock in this group get no intraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
30-day mortality
Time frame: 30 day
Inflammatory markers (CRP and white blood cell count)
Time frame: 4 days
Hemodynamic Parameters (Blood pressure, Heart rate)
Time frame: 3 days
Time till hemodynamic stabilization
Time frame: 30 days
Catecholamine dose and duration of catecholamines
Time frame: 30 days
Mean and area under the curve of serum lactate
Time frame: 48 hours
Creatinine clearance until stabilization
Time frame: 4 days
requirement for hemofiltration or dialysis
Time frame: 4 days
length of ICU stay
Time frame: 30 days
length of mechanical ventilation
Time frame: 30 days
SAPS-II Score
Time frame: 4 days
requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months
Time frame: 60 months
long-term mortality at 6, 12 and approximately 60 months
Time frame: 60 months
quality of life at 30 days and approximately 60 months
Time frame: 60 months
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Leipzig