Fact CheckerSign in

NCT03637205Completed

Extracorporeal Life Support in Cardiogenic Shock

Prospective Randomized Multicenter Study Comparing Extracorporeal Life Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Revascularization

Source: ClinicalTrials.gov · Last updated 13 Dec 2024

Brief summary (registry, in English)

The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality

Status (registry)
Completed
Study type
Interventional
Enrollment
420 (actual)
First submitted
13 Aug 2018
Start date
20 Jun 2019
Primary completion date
23 Dec 2022
Lead sponsor
Helios Health Institute GmbH
NCT number
NCT03637205

What you commit to

  • Study type: Interventional
  • Participants enrolled: 420
  • From 20 Jun 2019 to the primary completion date, 23 Dec 2022
  • 46 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other severe concomitant disease with limited life expectancy \<6 months

Other illness

  • Severe peripheral artery disease with impossibility to insert ECLS cannulae

Age

  • Age \<18 years or age \>75 years

Other

  • Resuscitation \>45 minutes
  • Mechanical cause of cardiogenic shock
  • Onset of shock \>12 h
  • Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
  • Pregnancy
  • Participation in another trial

Who the study is looking for

  • Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:
  • Planned revascularization (PCI or alternatively CABG)
  • Systolic blood pressure \<90 mmHg \>30 min or catecholamines required to maintain pressure \>90 mmHg during Systole
  • Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output \<30 ml/h
  • Arterial lactate \>3 mmol/l
  • Informed consent

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Aachen
Coordinator of this site? Confirm its status
AachenGermanyUnknown status
Zentralklinik Bad Berka GmbH
Coordinator of this site? Confirm its status
Bad BerkaGermanyUnknown status
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Coordinator of this site? Confirm its status
Bad FriedrichshallGermanyUnknown status
Kerckhoff-Klinik Forschungsgesellschaft mbH
Coordinator of this site? Confirm its status
Bad NauheimGermanyUnknown status
Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Universitätsklinikum Köln Klinik III für Innere Medizin
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
St. Johannes Hospital, Klinik für Innere Medizin I
Coordinator of this site? Confirm its status
DortmundGermanyUnknown status
Technische Universität Dresden
Coordinator of this site? Confirm its status
DresdenGermanyUnknown status
Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
Helios Klinikum Erfurt 3. Medizinische Klinik
Coordinator of this site? Confirm its status
ErfurtGermanyUnknown status
Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie
Coordinator of this site? Confirm its status
FrankfurtGermanyUnknown status
Klinikum Frankfurt Höchst
Coordinator of this site? Confirm its status
Frankfurt HöchstGermanyUnknown status
Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyUnknown status
Universitätsklinikum Gießen
Coordinator of this site? Confirm its status
GiessenGermanyUnknown status
Universitätsmedizin Göttingen, Klinik für Kardiologie und Pneumologie
Coordinator of this site? Confirm its status
GöttingenGermanyUnknown status
Universitätsmedizin Greifswald
Coordinator of this site? Confirm its status
GreifswaldGermanyUnknown status
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin III
Coordinator of this site? Confirm its status
HalleGermanyUnknown status
Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Asklepios Kliniken Hamburg GmbH
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Universitätsklinikum Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
SLK-Kliniken Heilbronn GmbH
Coordinator of this site? Confirm its status
HeilbronnGermanyUnknown status
Universitätsklinikum des Saarlandes Klinik für Innere Medizin III
Coordinator of this site? Confirm its status
HomburgGermanyUnknown status
Uniklinikum Jena Klinik für Innere Medizin I
Coordinator of this site? Confirm its status
JenaGermanyUnknown status
Klinikum Kassel GmbH
Coordinator of this site? Confirm its status
KasselGermanyUnknown status
Helios Klinikum Krefeld
Coordinator of this site? Confirm its status
KrefeldGermanyUnknown status
Asklepios Kliniken Langen-Seligenstadt GmbH
Coordinator of this site? Confirm its status
LangenGermanyUnknown status
Herzzentrum Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Universität Leipzig Klinik und Poliklinik für Kardiologie
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)
Coordinator of this site? Confirm its status
LübeckGermanyUnknown status
Klinikum der Stadt Ludwigshafen gGmbH
Coordinator of this site? Confirm its status
LudwigshafenGermanyUnknown status
Universitätsmedizin Mannheim
Coordinator of this site? Confirm its status
MannheimGermanyUnknown status
Kliniken Mariahilf GmbH
Coordinator of this site? Confirm its status
MönchengladbachGermanyUnknown status
Klinikum Nürnberg
Coordinator of this site? Confirm its status
NurembergGermanyUnknown status
Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II
Coordinator of this site? Confirm its status
RegensburgGermanyUnknown status
Kreiskliniken Reutlingen GmbH
Coordinator of this site? Confirm its status
ReutlingenGermanyUnknown status
Universitätsmedizin Rostock Zentrum für Innere Medizin
Coordinator of this site? Confirm its status
RostockGermanyUnknown status
Helios Klinikum Siegburg
Coordinator of this site? Confirm its status
SiegburgGermanyUnknown status
Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie
Coordinator of this site? Confirm its status
UlmGermanyUnknown status
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin
Coordinator of this site? Confirm its status
WiesbadenGermanyUnknown status
Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie
Coordinator of this site? Confirm its status
WinnendenGermanyUnknown status
Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie
Coordinator of this site? Confirm its status
WuppertalGermanyUnknown status
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I
Coordinator of this site? Confirm its status
WürzburgGermanyUnknown status
University Medical Centre Ljubljana
Coordinator of this site? Confirm its status
LjubljanaSloveniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.