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Danish Cardiogenic Shock Trial (DanShock)

Primary Purpose

Cardiogenic Shock Acute, Acute Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Conventional circulatory support
Impella CP
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aarhus University Hospital Skejby
  • Copenhagen University Hospital Rigshospitalet
  • Odense University Hospital
  • Charite Berlin
  • University Hospital Bonn
  • Dresden University Hospital
  • Düsseldorf University Hospital
  • UKE Hamburg
  • Hannover Medical School
  • Jena University Hospital
  • Brüderkrankenhaus Trier
  • University Hospital Würzburg
  • NHs Harefield Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Conventional circulatory support

Impella

Arm Description

Patients randomized to conventional circulatory support.

Patients randomized to Impella CP

Outcomes

Primary Outcome Measures

Death
Death from all causes

Secondary Outcome Measures

MACE
Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.
Composite saftey
Combined safety comprising major bleeding, vascular complications, and significant hemolysis.
Days alive out of hospital
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.

Full Information

First Posted
June 28, 2012
Last Updated
July 13, 2023
Sponsor
Odense University Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT01633502
Brief Title
Danish Cardiogenic Shock Trial
Acronym
DanShock
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2023 (Actual)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock Acute, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional circulatory support
Arm Type
Placebo Comparator
Arm Description
Patients randomized to conventional circulatory support.
Arm Title
Impella
Arm Type
Active Comparator
Arm Description
Patients randomized to Impella CP
Intervention Type
Device
Intervention Name(s)
Conventional circulatory support
Other Intervention Name(s)
Conventional circulatory support will be employed according to enrolling sites usual management.
Intervention Description
Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.
Intervention Type
Device
Intervention Name(s)
Impella CP
Other Intervention Name(s)
Impella CP, Abiomed
Intervention Description
Control group treated with Impella CP for a minimum of 48 hrs.
Primary Outcome Measure Information:
Title
Death
Description
Death from all causes
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
MACE
Description
Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.
Time Frame
minimum follow-up 6 months
Title
Composite saftey
Description
Combined safety comprising major bleeding, vascular complications, and significant hemolysis.
Time Frame
up to 6 months
Title
Days alive out of hospital
Description
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.
Time Frame
up tp 6 months
Other Pre-specified Outcome Measures:
Title
Hemodynamics
Description
Cardiac power index
Time Frame
up to 7 days
Title
Hemodynamics
Description
Lactate clearence
Time Frame
up to 7 days
Title
Hemodynamics
Description
Pulmonary artery pulsatility index
Time Frame
up to 7 days
Title
Health economics
Description
Cost of treatments
Time Frame
up to 6 months
Title
Renal function
Description
Development of acute kidney injury and need for dialysis
Time Frame
up to 30 days
Title
Bleeding
Description
Bleeding complications during admission
Time Frame
up to 30 days
Title
Revascularization strategy
Description
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)
Time Frame
During procedure
Title
Revascularization strategy
Description
Additional non culprit revascularization
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob E Moller, MD
Organizational Affiliation
Department of Cardiology, Odense University Hospital, Odense
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders Junker, MD
Organizational Affiliation
Department of Cardiology, Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christian Hassager, MD
Organizational Affiliation
Department of Cardiology, Copenhagen University Hospital Gentofte
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Shaefer, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nikos Werner, MD
Organizational Affiliation
University Hospital Trier
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Copenhagen University Hospital Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Charite Berlin
City
Berlin
Country
Germany
Facility Name
University Hospital Bonn
City
Bonn
Country
Germany
Facility Name
Dresden University Hospital
City
Dresden
Country
Germany
Facility Name
Düsseldorf University Hospital
City
Düsseldorf
Country
Germany
Facility Name
UKE Hamburg
City
Hamburg
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Facility Name
Jena University Hospital
City
Jena
Country
Germany
Facility Name
Brüderkrankenhaus Trier
City
Trier
Country
Germany
Facility Name
University Hospital Würzburg
City
Würzburg
Country
Germany
Facility Name
NHs Harefield Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36272450
Citation
Moller JE, Gerke O; DanGer Shock Investigators. Danish-German cardiogenic shock trial-DanGer shock: Trial design update. Am Heart J. 2023 Jan;255:90-93. doi: 10.1016/j.ahj.2022.10.078. Epub 2022 Oct 19.
Results Reference
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PubMed Identifier
31176289
Citation
Udesen NJ, Moller JE, Lindholm MG, Eiskjaer H, Schafer A, Werner N, Holmvang L, Terkelsen CJ, Jensen LO, Junker A, Schmidt H, Wachtell K, Thiele H, Engstrom T, Hassager C; DanGer Shock investigators. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial. Am Heart J. 2019 Aug;214:60-68. doi: 10.1016/j.ahj.2019.04.019. Epub 2019 May 6.
Results Reference
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Danish Cardiogenic Shock Trial

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