DanGer Shock Trial.

Study name	DanGer shock
Methods	Prospective randomised (1:1), multicentre, open‐label trial in people with STEMI complicated by cardiogenic shock
Participants	360 people with acute myocardial infarction cardiogenic shock undergoing primary percutaneous coronary intervention for STEMI.
Interventions	Percutaneous Impella CP 3.8L with the device implanted before revascularisation
Outcomes	Primary outcomes Death (follow‐up 6 months) Death from all causes Secondary outcomes MACE (timeframe 6 months) Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, rehospitalisation with heart failure. Combined safety (timeframe 6 months) Combined safety comprising major bleeding, vascular complications and significant haemolysis. Renal function (timeframe 6 months) Glomerular filtration rate, use dialysis SIRS (timeframe 1 month) Development of SIRS Health economics (timeframe 6 months) Cost of treatments Haemodynamics (timeframe 7 days) Cardiac Power Index, lactate clearance, pulmonary capillary wedge pressure
Starting date	December 2012
Contact information	Jacob E Moller, MD jem@dadlnet.dk
Notes	The DanGer trial aims to be the first adequately powered randomised trial to address whether mechanical circulatory left ventricular support with Impella CP can improve survival in acute myocardial infarction cardiogenic shock. The baseline characteristics of the first 100 randomised participants were published in the American Heart Journal (DanGer Shock 2019), the participants were in profound cardiogenic shock, and people with out‐of‐hospital cardiac arrests were excluded. Originally registered as the Danish Cardiogenic shock trial and the ALLOASSIST trial; due to slow recruitment, the 2 trials have been joined.