Short summary

One of the leading causes of death after acute myocardial infarction is development of cardiogenic shock where mortality rates still exceeds 50%. The main objective of the DanShock study is to assess whether mechanical restoration of cardiac output using the Impella CP device will be associated with improved survival after myocardial infarction complicated by cardiogenic shock. Besides the direct benefit of reduced mortality this will possibly be associated with reduced morbidity, reduced damage to the heart, and reduced length of hospitalization.

Rationale

Even though the overall prognosis of acute myocardial infraction has improved dramatically over the past decades this is not the case for patients with acute myocardial infarction complicated by cardiogenic shock. Thus there is a great need for optimized management of these desperately ill patients. The planned study will provide insight in whether a potentially costly aggressive management to restore cardiac output compared with conventional management will improve survival. A positive result with improved survival in the Impella group will have an impact on the management of these patients nationally and internationally. A negative result will avoid unnecessary use of resources that can be better utilized elsewhere, thus has importance for patients nationally.

Description of the cohort

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 > or equal to 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)
3. Left ventricular ejection fraction of less than 45%.

Data and biological material

Prospective collection of clinical, angiographic, hemodynamic and outcome data. Primary endpoint all-cause mortality.

Collaborating researchers and departments

Heart Center, Copenhagen University Hospital Rigshospitalet

• Associate Professor and consultant Thomas Engstrøm
• Professor and consultant Christian Hassager
• Consultant Lene Holmvang
• Senior registrar Mathias Lindholm, PhD.

Department of Cardiology and Cardiac Intensive Care Unit, Aarhus University Hospital

• Consultant Hans Eiskjær
• Consultant Anne Kaltoft, DMSc.

Department of Cardiology and Cardiac Intensive Care Unit, Odense University Hospital

• Consultant Anders Junker, PhD
• Associate professor and consultant Lisette Okkels Jensen
• Associate professor and consultant Henrik Schmidt

Department of Cardiology and Cardiac Intensive Care Unit, Aalborg University Hospital

• Consultant Jan Ravkilde, DMSc
• Consultant Jan Ravkilde, PhD
• Consultant and Senior investigator Inge de Haas

Department of Public Health, Copenhagen University

• Associate professor and consultant Kristian Wachtell

Emergency Medical Services, The Capital Region of Denmark

• Medical Director Freddy Lippert