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 : March 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cardiogenic Shock Acute Acute Myocardial Infarction||Device: Conventional circulatory support Device: Impella CP||Not Applicable|
|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 :||July 2023|
|Estimated Study Completion Date :||January 2024|
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: up to 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.
- Composite saftey [ Time Frame: up to 6 months ]Combined safety comprising major bleeding, vascular complications, and significant hemolysis.
- Days alive out of hospital [ Time Frame: up tp 6 months ]Days alive and out of hospital; calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient.
- Hemodynamics [ Time Frame: up to 7 days ]Cardiac power index
- Hemodynamics [ Time Frame: up to 7 days ]Lactate clearence
- Hemodynamics [ Time Frame: up to 7 days ]Pulmonary artery pulsatility index
- Health economics [ Time Frame: up to 6 months ]Cost of treatments
- Renal function [ Time Frame: up to 30 days ]Development of acute kidney injury and need for dialysis
- Bleeding [ Time Frame: up to 30 days ]Bleeding complications during admission
- Revascularization strategy [ Time Frame: During procedure ]Syntax score ( a grading system that evaluates the complexity and prognosis of patients undergoing percutaneous coronary intervention, higher scores denotes more complex disase and higher risk)
- Revascularization strategy [ Time Frame: up to 6 months ]Additional non culprit revascularization
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
Cardiogenic shock of less than 24 hours' duration, confirmed by:
- peripheral signs of tissue hypoperfusion (arterial blood lactate ≥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), and
- Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.
- Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).
- Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).
- Severe aorta valve regurgitation/stenosis.
- Predominant right ventricular failure.
- Out of hospital cardiac arrest with persistent Glasgow coma scale <8 after return of spontaneous circulation.
- Shock duration>24 hours.
- Known heparin intolerance.
- Already established mechanical circulatory support
- Do not resuscitate wish.
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
|Contact: Jacob E Moller, MDfirstname.lastname@example.org|
|Contact: Hans Eiskjær, MDemail@example.com|
|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: Christian Hassager, MD +4535450887 firstname.lastname@example.org|
|Sub-Investigator: Thomas Engstrøm, MD|
|Sub-Investigator: Lene Holmvang, MD|
|Odense University Hospital||Recruiting|
|Odense, Denmark, DK-5000|
|Contact: Jacob E Møller, MD email@example.com|
|Sub-Investigator: Lisette O Jensen, MD|
|Sub-Investigator: Henrik Schmidt, MD|
|Contact: Carsten Skruk, MD|
|University Hospital Bonn||Recruiting|
|Contact: Sebastian Zimmer, Professor firstname.lastname@example.org|
|Dresden University Hospital||Recruiting|
|Contact: Axel Linke, Professor email@example.com|
|Sub-Investigator: Norman Mangner, Professor|
|Düsseldorf University Hospital||Recruiting|
|Contact: Ralf Westenfeld, Professor Ralf.Westenfeld@med.uni-duesseldorf.de|
|Contact: Dirk Westermann, MD|
|Hannover Medical School||Recruiting|
|Contact: Andreas Schaefer, Professor Schaefer.Andreas@mh-hannover.de|
|Jena University Hospital||Recruiting|
|Contact: Christian Schulze, Professor Christian.Schulze@med.uni-jena.de|
|Brüderkrankenhaus Trier||Active, not recruiting|
|University Hospital Würzburg||Recruiting|
|Contact: Peter Nordbeck, MD|
|NHs Harefield Hospital||Recruiting|
|London, United Kingdom|
|Contact: Vasileios Panoulas, Professor|
|Principal Investigator:||Jacob E Moller, MD||Department of Cardiology, Odense University Hospital, Odense|
|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 Trier|
|Responsible Party:||Jacob Moller, Professor in Cardiology, Odense University Hospital|
|Other Study ID Numbers:||
|First Posted:||July 4, 2012 Key Record Dates|
|Last Update Posted:||March 13, 2023|
|Last Verified:||March 2023|