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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.
 
ClinicalTrials.gov Identifier: NCT01633502
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : May 14, 2024
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Hannover Medical School
University Hospital, Bonn
Jena University Hospital
University Hospital Dresden
Heinrich-Heine University, Duesseldorf
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
Royal Brompton & Harefield NHS Foundation Trust
Wuerzburg University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Jacob Moller, Odense University Hospital

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : July 2023
Actual Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Death [ Time Frame: up to 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. Composite saftey [ Time Frame: up to 6 months ]
    Combined safety comprising major bleeding, vascular complications, and significant hemolysis.

  3. 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.


Other Outcome Measures:
  1. Hemodynamics [ Time Frame: up to 7 days ]
    Cardiac power index

  2. Hemodynamics [ Time Frame: up to 7 days ]
    Lactate clearence

  3. Hemodynamics [ Time Frame: up to 7 days ]
    Pulmonary artery pulsatility index

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

  5. Renal function [ Time Frame: up to 30 days ]
    Development of acute kidney injury and need for dialysis

  6. Bleeding [ Time Frame: up to 30 days ]
    Bleeding complications during admission

  7. 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)

  8. Revascularization strategy [ Time Frame: up to 6 months ]
    Additional non culprit revascularization


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Denmark
Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Odense University Hospital
Odense, Denmark, DK-5000
Germany
Charite Berlin
Berlin, Germany
University Hospital Bonn
Bonn, Germany
Dresden University Hospital
Dresden, Germany
Düsseldorf University Hospital
Düsseldorf, Germany
UKE Hamburg
Hamburg, Germany
Hannover Medical School
Hannover, Germany
Jena University Hospital
Jena, Germany
Brüderkrankenhaus Trier
Trier, Germany
University Hospital Würzburg
Würzburg, Germany
United Kingdom
NHs Harefield Hospital
London, United Kingdom
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital Skejby
Hannover Medical School
University Hospital, Bonn
Jena University Hospital
University Hospital Dresden
Heinrich-Heine University, Duesseldorf
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
Royal Brompton & Harefield NHS Foundation Trust
Wuerzburg University Hospital
Rigshospitalet, Denmark
Investigators
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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
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Jacob Moller, Professor in Cardiology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01633502    
Other Study ID Numbers: DanShock-01
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases