Myocardial Infarction, Shock, Cardiogenic
Conditions
Keywords
Acute myocardial infarction, cardiogenic shock, percutaneous coronary intervention, intraaortic balloon counterpulsation, Acute myocardial infarction - cardiogenic shock
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.
Interventions
DEVICEIntraaortic balloon pump
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with * intended revascularization (PCI or CABG) * Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole * Signs of pulmonary congestion * Signs of impaired organ perfusion with at least one of the following: * Altered mental status * Cold, clammy skin * Urine output \<30 ml/h * Serum lactate \>2mmol/l * Informed consent
Exclusion criteria
* Resuscitation \> 30 minutes * Cerebral deficit with fixed dilated pupils * No intrinsic heart action * Mechanical infarction complication * Onset of shock \> 12 h * Severe peripheral artery disease * Aortic regurgitation \> II.° * Age \> 90 years * shock of other cause * Other severe concomitant disease * participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day mortality | 30 day |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine clearance until stabilization | 4 days |
| requirement for hemofiltration or dialysis | 4 days |
| length of ICU stay | 30 days |
| length of mechanical ventilation | 30 days |
| Inflammatory markers (CRP and white blood cell count) | 4 days |
| Hemodynamic Parameters (Blood pressure, Heart rate) | 3 days |
| SAPS-II Score | 4 days |
| Catecholamine dose and duration of catecholamines | 30 days |
| Mean and area under the curve of serum lactate | 48 hours |
| requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months | 60 months |
| long-term mortality at 6, 12 and approximately 60 months | 60 months |
| quality of life at 30 days and approximately 60 months | 60 months |
| Time till hemodynamic stabilization | 30 days |
Countries
Germany
Outcome results
None listed