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. Read our disclaimer for details. 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
Aarhus University Hospital
Aalborg Universitetshospital
Odense University Hospital
Information provided by (Responsible Party):
Jacob E Moller, Rigshospitalet, Denmark

Brief Summary:
Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella cVAD. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Death [ Time Frame: minimum follow-up 6 months ]
    Death from all causes

Secondary Outcome Measures :
  1. 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.

  2. Combined safety [ Time Frame: 6 months ]
    Combined safety comprising major bleeding, vascular complications, and significant hemolysis.

  3. 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.

  4. Renal function [ Time Frame: 6 months ]
    Measured glomerular filtration rate, use dialysis.

  5. SIRS [ Time Frame: 1 months ]
    Development of systemic inflammatory response syndrome

  6. Health economics [ Time Frame: 6 months ]
    Cost of treatments

  7. Hemodynamics [ Time Frame: 7 days ]
    Cardiac power index, lactate clearance, pulmonary capillary wedge pressure

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. 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
  3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.

Exclusion Criteria:

  1. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).
  2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).
  3. Severe aorta valve regurgitation/stenosis.
  4. Predominant right ventricular failure.
  5. Out of hospital cardiac arrest with persistent Glasgow coma scale <8 after return of spontaneous circulation.
  6. Shock duration>24 hours.
  7. Known heparin intolerance.
  8. Do not resuscitate wish.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01633502

Contact: Jacob E Moller, MD -4535450887
Contact: Hans Eiskjær, MD

Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, DK-9100
Contact: Jan Ravkilde, MD   
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   
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   
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   
Principal Investigator: Anders Junker, MD         
Sub-Investigator: Lisette O Jensen, MD         
Sub-Investigator: Henrik Schmidt, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg Universitetshospital
Odense University Hospital
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

Responsible Party: Jacob E Moller, Consultant in Cardiology, Rigshospitalet, Denmark Identifier: NCT01633502     History of Changes
Other Study ID Numbers: DanShock-01
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Shock, Cardiogenic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases