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NCT Number: NCT01633502

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.

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Key information

Conditions

Cardiogenic Shock Acute Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital Skejby, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional circulatory support

Device

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.

Impella CP

Device

Control group treated with Impella CP for a minimum of 48 hrs.

Other names: Impella CP, Abiomed

Primary outcomes

  1. Death

    Time frame: up to 6 months

    Death from all causes

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DanShock

Important dates

Study start
2012
Primary completion
2023
Study completion
2024
First posted
Jul 4, 2012
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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