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Danish Cardiogenic Shock Trial (DanShock)

This study is currently recruiting participants.
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Aarhus University Hospital
Aalborg Universityhospital
Odense University Hospital
Information provided by (Responsible Party):
Jacob E Moller, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01633502
First received: June 28, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Cardiogenic Shock Acute
Acute Myocardial Infarction
 Device: Conventional circulatory support
Device: Impella cVAD
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Shock
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Death [ Time Frame: minimum follow-up 6 months ] [ Designated as safety issue: Yes ]
    Death from all causes


Secondary Outcome Measures:
  • MACE [ Time Frame: minimum follow-up 6 months ] [ Designated as safety issue: Yes ]
    Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.

  • Combined safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Combined safety comprising major bleeding, vascular complications, and significant hemolysis.

  • LV function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    LV function assessed with magnetic resonance imaging (LV ejection fraction, myocardial salvage and final infarct size)/ echocardiography LVEF by 3D echocardiography, Global longitudinal strain.

  • Renal function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured glomerular filtration rate, use dialysis.

  • SIRS [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    Development of systemic inflammatory response syndrome

  • Health economics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cost of treatments

  • Hemodynamics [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Cardiac power index, lactate clearance, pulmonary capillary wedge pressure


Estimated Enrollment: 360
Study Start Date: December 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. Do not resuscitate wish.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633502

Contacts
Contact: Jacob E Moller, MD -4535450887 jem@dadlnet.dk
Contact: Hans Eiskjær, MD heis@dadlnet.dk

Locations
Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark, DK-9100
Contact: Jan Ravkilde, MD         jan.ravkilde@rn.dk    
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         Heis@dadlnet.dk    
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     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 Not yet 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            
Sponsors and Collaborators
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg Universityhospital
Odense University Hospital
Investigators
Principal Investigator: Jacob E Moller, MD Heart Center, Copenhagen University Hospital Rigshospitalet
Study Chair: Hans Eiskjær, MD Department of Cardiology, Aarhus University Hospital Skejby
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
  More Information

No publications provided

Responsible Party: Jacob E Moller, Consultant in Cardiology, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01633502     History of Changes
Other Study ID Numbers: DanShock-01
Study First Received: June 28, 2012
Last Updated: December 13, 2012
Health Authority: Denmark: Good Clinical Practice unit for the Capital Region

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

ClinicalTrials.gov processed this record on June 17, 2013