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
- Diseases
- Coronary artery disease
- 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
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Zentralklinik Bad Berka GmbH Coordinator of this site? Confirm its status | Bad Berka | Germany | Unknown status |
| SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald Coordinator of this site? Confirm its status | Bad Friedrichshall | Germany | Unknown status |
| Kerckhoff-Klinik Forschungsgesellschaft mbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Unknown status |
| Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| BG Klinikum Unfallkrankenhaus Berlin gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsklinikum Köln Klinik III für Innere Medizin Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| St. Johannes Hospital, Klinik für Innere Medizin I Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Helios Klinikum Erfurt 3. Medizinische Klinik Coordinator of this site? Confirm its status | Erfurt | Germany | Unknown status |
| Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Klinikum Frankfurt Höchst Coordinator of this site? Confirm its status | Frankfurt Höchst | Germany | Unknown status |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Universitätsklinikum Gießen Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Universitätsmedizin Göttingen, Klinik für Kardiologie und Pneumologie Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Universitätsmedizin Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin III Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Heilbronn | Germany | Unknown status |
| Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Uniklinikum Jena Klinik für Innere Medizin I Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Klinikum Kassel GmbH Coordinator of this site? Confirm its status | Kassel | Germany | Unknown status |
| Helios Klinikum Krefeld Coordinator of this site? Confirm its status | Krefeld | Germany | Unknown status |
| Asklepios Kliniken Langen-Seligenstadt GmbH Coordinator of this site? Confirm its status | Langen | Germany | Unknown status |
| Herzzentrum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universität Leipzig Klinik und Poliklinik für Kardiologie Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin) Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Klinikum der Stadt Ludwigshafen gGmbH Coordinator of this site? Confirm its status | Ludwigshafen | Germany | Unknown status |
| Universitätsmedizin Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Kliniken Mariahilf GmbH Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Unknown status |
| Klinikum Nürnberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Kreiskliniken Reutlingen GmbH Coordinator of this site? Confirm its status | Reutlingen | Germany | Unknown status |
| Universitätsmedizin Rostock Zentrum für Innere Medizin Coordinator of this site? Confirm its status | Rostock | Germany | Unknown status |
| Helios Klinikum Siegburg Coordinator of this site? Confirm its status | Siegburg | Germany | Unknown status |
| Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin Coordinator of this site? Confirm its status | Wiesbaden | Germany | Unknown status |
| Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie Coordinator of this site? Confirm its status | Winnenden | Germany | Unknown status |
| Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie Coordinator of this site? Confirm its status | Wuppertal | Germany | Unknown status |
| Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.