Danish Cardiogenic Shock Trial (DanShock)
|ClinicalTrials.gov Identifier: NCT01633502|
Recruitment Status : Unknown
Verified December 2012 by Jacob E Moller, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : July 4, 2012
Last Update Posted : December 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cardiogenic Shock Acute Acute Myocardial Infarction||Device: Conventional circulatory support Device: Impella cVAD||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||April 2018|
Placebo Comparator: Conventional circulatory support
Patients randomized to conventional circulatory support.
Device: Conventional circulatory support
Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.
Other Name: Conventional circulatory support will be employed according to enrolling sites usual management.
Active Comparator: Impella
Patients randomized to Impella cVAD
Device: Impella cVAD
Control group treated with Impella cVAD for a minimum of 48 hrs.
Other Name: Impella cVAD, Abiomed
- Death [ Time Frame: minimum follow-up 6 months ]Death from all causes
- MACE [ Time Frame: minimum follow-up 6 months ]Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.
- Combined safety [ Time Frame: 6 months ]Combined safety comprising major bleeding, vascular complications, and significant hemolysis.
- LV function [ Time Frame: 6 months ]LV function assessed with magnetic resonance imaging (LV ejection fraction, myocardial salvage and final infarct size)/ echocardiography LVEF by 3D echocardiography, Global longitudinal strain.
- Renal function [ Time Frame: 6 months ]Measured glomerular filtration rate, use dialysis.
- SIRS [ Time Frame: 1 months ]Development of systemic inflammatory response syndrome
- Health economics [ Time Frame: 6 months ]Cost of treatments
- Hemodynamics [ Time Frame: 7 days ]Cardiac power index, lactate clearance, pulmonary capillary wedge pressure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633502
|Aalborg University Hospital||Not yet recruiting|
|Aalborg, Denmark, DK-9100|
|Contact: Jan Ravkilde, MD firstname.lastname@example.org|
|Principal Investigator: Jan Ravkilde, MD|
|Sub-Investigator: Hans Henrik Tiltsted, MD|
|Sub-Investigator: Inge de-Haas, MD|
|Aarhus University Hospital Skejby||Not yet recruiting|
|Aarhus, Denmark, 8200|
|Contact: Hans Eiskjær, MD Heis@dadlnet.dk|
|Principal Investigator: Hans Eiskjær, MD|
|Sub-Investigator: Jens F Lassen, MD|
|Sub-Investigator: Anne Kaltoft, MD|
|Sub-Investigator: Hanne B Ravn, MD|
|Copenhagen University Hospital Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Jacob E Moller, MD +4535450887 email@example.com|
|Sub-Investigator: Christian Hassager, MD|
|Sub-Investigator: Thomas Engstrøm, MD|
|Sub-Investigator: Lene Holmvang, MD|
|Sub-Investigator: Matias G Lindholm, MD|
|Odense University Hospital||Not yet recruiting|
|Odense, Denmark, DK-5000|
|Contact: Anders Junker, MD firstname.lastname@example.org|
|Principal Investigator: Anders Junker, MD|
|Sub-Investigator: Lisette O Jensen, MD|
|Sub-Investigator: Henrik Schmidt, MD|
|Principal Investigator:||Jacob E Moller, MD||Heart Center, Copenhagen University Hospital Rigshospitalet|
|Study Chair:||Hans Eiskjær, MD||Aarhus University Hospital|
|Study Chair:||Jan Ravkilde, MD||Department of Cardiology, Aalborg University Hospital|
|Study Chair:||Anders Junker, MD||Department of Cardiology, Odense University Hospital|
|Study Chair:||Kristian Wachtell, MD||Department of Cardiology, Copenhagen University Hospital Gentofte|
|Study Chair:||Freddy Lippert, MD||Emergency Medical Services, Head Office, Capital Region, Denmark|