Acute Myocardial Infarction, Cardiogenic Shock, Complications
Conditions
Keywords
cardiogenic shock, infarction, multivessel coronary artery disease, angioplasty
Brief summary
The study compares the therapies of instant multivessel balloon angioplasty plus stent implantation or the balloon angioplasty plus stent implantation of the infarct artery alone with any possible graduated later treatment of the other vessels in patients with acute myocardial infarction with cardioganic shock. The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.
Interventions
PROCEDUREImmediate multivessel PCI
PROCEDURECulprit Lesion only PCI
Sponsors
European Commission
German Cardiac Society
Deutsche Stiftung für Herzforschung
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University of Luebeck
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 infarction (STEMI or NSTEMI) with obligatory: I) Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III) 1. Systolic blood pressure less than 90 mmHg for more than 30 min or 2. catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent
Exclusion criteria
* Resuscitation more than 30 minutes * No intrinsic heart action * Cerebral deficit with fixed dilated pupils (not drug-induced) * Need for primary urgent bypass surgery (to be determined after diagnostic angiography) * Single vessel disease * Mechanical cause of cardiogenic shock * Onset of shock more than 12 h * Massive lung emboli * Age more than 90 years * Shock of other cause (bradycardia, sepsis, hypovolemia, etc.) * Other severe concomitant disease with limited life expectancy \<6 months * Pregnancy * Known severe renal insufficiency (creatinine clearance \<30 ml/kg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day mortality and/or severe renal failure requiring renal replacement therapy | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Requirement of renal replacement therapy | 30 days |
| Time to hemodynamic stabilization | 30 days |
| Duration of catecholamine therapy | 30 days |
| Serial creatinine-level creatinine-clearance | 30 days |
| Length of ICU-stay | 30 days |
| Serial intensive care scoring (SAPS-II score) until stabilization | 30 days |
| Requirement and length of mechanical ventilation | 30 days |
| All-cause death within 12 months follow-up | 12 months |
| Recurrent infarction within 30-days follow-up | 30 days |
| 30-day mortality | 30 days |
| Rehospitalization for congestive heart failure within 12 months follow-up | 12 months |
| Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months | 12 months |
| Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up | 12 months |
| Peak creatine kinase level during hospital stay | 30 days |
| Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D) | 12 months |
| Maximum creatine kinase-MB level | 30 days |
| Maximum troponin level | 30 days |
| Recurrent infarction within 12 months follow-up | 12 months |
| Death or recurrent infarction at 12 months follow-up | 12 months |
Countries
Germany
Outcome results
None listed