Acute; Myocardial Infarction, Complications, Cardiogenic Shock
Conditions
Keywords
Cardiogenic shock, acute myocardial infarction, mild hypothermia
Brief summary
Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.
Interventions
PROCEDUREMild hypothermia
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
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
* Acute myocardial infarction complicated by cardiongenic shock * Patients on mechanical ventilation at time of randomization
Exclusion criteria
* Out of hospital resuscitation with indication for mild hypothermia * mechanical complications after acute myocardial infarction * duration of cardiogenic shock \> 12 hours * age \> 90 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Power Index after 24 hr. | 24 hours | Cardiac Power Index after 24 hours as surrogate endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of hemodynamics over the first 48 hr. | During first 48 hr | — |
| Catecholamine dose and duration of catecholamine support | 30 days | — |
| Length of ICU-stay | 30 days | — |
| Length of mechanical ventilation | 30 days | — |
| 30-days mortality | 30 days | — |
| Severe and moderate bleeding complications (GUSTO-definition) | 30 days | — |
| Sepsis | 30 days | — |
| Pneumonia | 30 days | — |
| Stroke | 30 days | — |
| SAPS-II-Score | 96 hours | Simplified Acute Physiology Score for the first 4 days |
Countries
Germany
Outcome results
None listed