Clinical trial NCT01633502: Danish Cardiogenic Shock Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock Acute
Acute Myocardial Infarction
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
name: Hannover Medical School
name: University Hospital, Bonn
name: Jena University Hospital
name: University Hospital Dresden
name: Heinrich-Heine University, Duesseldorf
name: Universitätsklinikum Hamburg-Eppendorf
name: Charite University, Berlin, Germany
name: Royal Brompton & Harefield NHS Foundation Trust
name: Wuerzburg University Hospital
name: Rigshospitalet, Denmark
First posted: 2012-07-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Death
timeFrame: up to 6 months
Secondary outcomes:
measure: MACE
timeFrame: minimum follow-up 6 months
measure: Composite saftey
timeFrame: up to 6 months
measure: Days alive out of hospital
timeFrame: up tp 6 months
Other outcomes:
measure: Hemodynamics
timeFrame: up to 7 days
measure: Hemodynamics
timeFrame: up to 7 days
measure: Hemodynamics
timeFrame: up to 7 days
measure: Health economics
timeFrame: up to 6 months
measure: Renal function
timeFrame: up to 30 days
measure: Bleeding
timeFrame: up to 30 days
measure: Revascularization strategy
timeFrame: During procedure
measure: Revascularization strategy
timeFrame: up to 6 months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Berlin
country: Germany
facility: Charite Berlin
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Dresden
country: Germany
facility: Dresden University Hospital
city: Düsseldorf
country: Germany
facility: Düsseldorf University Hospital
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Hannover
country: Germany
facility: Hannover Medical School
city: Jena
country: Germany
facility: Jena University Hospital
city: Trier
country: Germany
facility: Brüderkrankenhaus Trier
city: Würzburg
country: Germany
facility: University Hospital Würzburg
city: London
country: United Kingdom
facility: NHs Harefield Hospital
Study officials:
affiliation: Department of Cardiology, Odense University Hospital, Odense
name: Jacob E Moller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Odense University Hospital
name: Anders Junker, MD
role: STUDY_CHAIR
affiliation: Department of Cardiology, Copenhagen University Hospital Gentofte
name: Christian Hassager, MD
role: STUDY_CHAIR
affiliation: Hannover Medical School
name: Andreas Shaefer, MD
role: STUDY_CHAIR
affiliation: University Hospital Trier
name: Nikos Werner, MD
role: STUDY_CHAIR
References:
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.
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.
citation: Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Schmidt H, Terkelsen CJ, Christensen S, Christiansen EH, Linke A, Woitek FJ, Westenfeld R, Mobius-Winkler S, Wachtell K, Ravn HB, Lassen JF, Boesgaard S, Gerke O, Hassager C; DanGer Shock Investigators. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.