Acute Myocardial Infarction, Cardiogenic Shock Acute
Conditions
Brief summary
Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella CP. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.
Interventions
Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.
DEVICEImpella CP
Control group treated with Impella CP for a minimum of 48 hrs.
Sponsors
Aarhus University Hospital Skejby
Hannover Medical School
University Hospital, Bonn
Jena University Hospital
University Hospital Dresden
Heinrich-Heine University, Duesseldorf
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
Royal Brompton & Harefield NHS Foundation Trust
Wuerzburg University Hospital
Rigshospitalet, Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and 2. Cardiogenic shock of less than 24 hours' duration, confirmed by: * peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 \<55% with a normal PaO2) and * systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and 3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \>1,6.
Exclusion criteria
1. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis). 2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall). 3. Severe aorta valve regurgitation/stenosis. 4. Predominant right ventricular failure. 5. Out of hospital cardiac arrest with persistent Glasgow coma scale \<8 after return of spontaneous circulation. 6. Shock duration\>24 hours. 7. Known heparin intolerance. 8. Already established mechanical circulatory support 9. Do not resuscitate wish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | up to 6 months | Death from all causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | minimum follow-up 6 months | Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure. |
| Composite saftey | up to 6 months | Combined safety comprising major bleeding, vascular complications, and significant hemolysis. |
| Days alive out of hospital | up tp 6 months | Days alive and out of hospital; calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamics | up to 7 days | Cardiac power index |
| Revascularization strategy | During procedure | Syntax score ( a grading system that evaluates the complexity and prognosis of patients undergoing percutaneous coronary intervention, higher scores denotes more complex disase and higher risk) |
| Health economics | up to 6 months | Cost of treatments |
| Renal function | up to 30 days | Development of acute kidney injury and need for dialysis |
| Bleeding | up to 30 days | Bleeding complications during admission |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed