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 : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiogenic Shock Acute Acute Myocardial Infarction||Device: Conventional circulatory support Device: Impella CP||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 :||September 2022|
|Estimated Study Completion Date :||January 2023|
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 CP
Device: Impella CP
Control group treated with Impella CP for a minimum of 48 hrs.
Other Name: Impella CP, 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.
- Renal function [ Time Frame: 6 months ]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
|Aarhus University Hospital Skejby||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Hans Eiskjær, MD Heis@dadlnet.dk|
|Principal Investigator: Hans Eiskjær, MD|
|Sub-Investigator: Christian J Therkelsen, 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||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|
|University Hospital Bonn||Not yet recruiting|
|Contact: Nikos Werner, Professor firstname.lastname@example.org|
|Hannover Medical School||Not yet recruiting|
|Contact: Andreas Schaefer, Professor Schaefer.Andreas@mh-hannover.de|
|Principal Investigator:||Jacob E Moller, MD||Heart Center, Copenhagen University Hospital Rigshospitalet|
|Study Chair:||Hans Eiskjær, MD||Aarhus University Hospital|
|Study Chair:||Anders Junker, MD||Department of Cardiology, Odense University Hospital|
|Study Chair:||Christian Hassager, MD||Department of Cardiology, Copenhagen University Hospital Gentofte|
|Study Chair:||Andreas Shaefer, MD||Hannover Medical School|
|Study Chair:||Nikos Werner, MD||University Hospital, Bonn|