Danish Cardiogenic Shock Trial (DanShock)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01633502|
Recruitment Status : 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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|