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Danish Cardiogenic Shock Trial (DanShock)

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ClinicalTrials.gov Identifier: NCT01633502
Recruitment Status : Recruiting
First Posted : July 4, 2012
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Aalborg University Hospital
Hannover Medical School
University Hospital, Bonn
Information provided by (Responsible Party):
Jacob Moller, Odense University Hospital

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 CP. 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 CP Phase 3

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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 : September 2022
Estimated Study Completion Date : January 2023

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 CP
Device: Impella CP
Control group treated with Impella CP for a minimum of 48 hrs.
Other Name: Impella CP, 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. Renal function [ Time Frame: 6 months ]
    glomerular filtration rate, use dialysis.

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

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

  6. 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
Criteria

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. Already established mechanical circulatory support
  9. 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 ClinicalTrials.gov identifier (NCT number): NCT01633502


Contacts
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Contact: Jacob E Moller, MD -4566113333 jem@dadlnet.dk
Contact: Hans Eiskjær, MD heis@dadlnet.dk

Locations
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Denmark
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    jem@dadlnet.dk   
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       anders.junker@ouh.regionsyddanmark.dk   
Principal Investigator: Anders Junker, MD         
Sub-Investigator: Lisette O Jensen, MD         
Sub-Investigator: Henrik Schmidt, MD         
Germany
University Hospital Bonn Recruiting
Bonn, Germany
Contact: Jan Malte Sinning, Professor       jan-malte.sinning@ukbonn.de   
Dresden University Hospital Recruiting
Dresden, Germany
Contact: Axel Linke, Professor       axel.linke@herzzentrum-dresden.com   
Düsseldorf University Hospital Not yet recruiting
Düsseldorf, Germany
Contact: Ralf Westenfeld, Professor       Ralf.Westenfeld@med.uni-duesseldorf.de   
Hannover Medical School Recruiting
Hannover, Germany
Contact: Andreas Schaefer, Professor       Schaefer.Andreas@mh-hannover.de   
Jena University Hospital Recruiting
Jena, Germany
Contact: Christian Schulze, Professor       Christian.Schulze@med.uni-jena.de   
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital Skejby
Aalborg University Hospital
Hannover Medical School
University Hospital, Bonn
Investigators
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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

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Responsible Party: Jacob Moller, Professor in Cardiology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01633502     History of Changes
Other Study ID Numbers: DanShock-01
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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