Danish Cardiogenic Shock Trial (DanShock)

Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myocardial Infarction; Cardiogenic Shock Acute
• Intervention / Treatment: Device: Conventional circulatory support; Device: Impella CP

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital Skejby
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital Rigshospitalet
  • Odense, Denmark, DK-5000
    • Odense University Hospital
• Germany
  • Berlin, Germany
    • Charite Berlin
  • Bonn, Germany
    • University Hospital Bonn
  • Dresden, Germany
    • Dresden University Hospital
  • Düsseldorf, Germany
    • Düsseldorf University Hospital
  • Hamburg, Germany
    • UKE Hamburg
  • Hannover, Germany
    • Hannover Medical School
  • Jena, Germany
    • Jena University Hospital
  • Trier, Germany
    • Brüderkrankenhaus Trier
  • Würzburg, Germany
    • University Hospital Würzburg
• United Kingdom
  • London, United Kingdom
    • NHs Harefield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Impella CP, Abiomed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death from all causes	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.	minimum follow-up 6 months
Composite saftey	Combined safety comprising major bleeding, vascular complications, and significant hemolysis.	up to 6 months
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.	up tp 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamics	Cardiac power index	up to 7 days
Hemodynamics	Lactate clearence	up to 7 days
Hemodynamics	Pulmonary artery pulsatility index	up to 7 days
Health economics	Cost of treatments	up to 6 months
Renal function	Development of acute kidney injury and need for dialysis	up to 30 days
Bleeding	Bleeding complications during admission	up to 30 days
Revascularization strategy	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)	During procedure
Revascularization strategy	Additional non culprit revascularization	up to 6 months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Charite University, Berlin, Germany; Hannover Medical School; Aarhus University Hospital Skejby; Rigshospitalet, Denmark; Heinrich-Heine University, Duesseldorf; University Hospital, Bonn; Royal Brompton & Harefield NHS Foundation Trust; Universitätsklinikum Hamburg-Eppendorf; Wuerzburg University Hospital; Jena University Hospital; University Hospital Dresden
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: June 29, 2012
• First Posted (Estimated): July 4, 2012

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: DanShock-01