Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-07 @ 10:19 PM
Study NCT ID:
NCT03637205
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Life Support in Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days', 'description': '30-day all-cause death after randomization according to the intention-to-treat principle'}], 'secondaryOutcomes': [{'measure': 'Time to death within 6 and 12 months follow-up', 'timeFrame': '6 and 12 months'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': '0 to 10 days'}, {'measure': 'Time to hemodynamic stabilization', 'timeFrame': '0 to 10 days'}, {'measure': 'Duration of catecholamine therapy', 'timeFrame': '0 to 10 days'}, {'measure': 'Serial creatinine-level and creatinine-clearance', 'timeFrame': '0 to 10 days from time of randomization until stabilization', 'description': 'Creatinine-clearance (Cockcroft-Gault-Formula)'}, {'measure': 'Length of ICU stay', 'timeFrame': '0 to 11 days'}, {'measure': 'Length of hospital stay', 'timeFrame': '0 to 14 days'}, {'measure': 'Serial SAPS-II score', 'timeFrame': '0 to 11 days'}, {'measure': 'Mean and area under the curve of arterial lactate', 'timeFrame': '0 to 14 days'}, {'measure': 'Acute renal failure requiring renal replacement therapy', 'timeFrame': '0 to 14 days'}, {'measure': 'Cerebral performance category (CPC)', 'timeFrame': '30 days, 6 and 12 months'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '6 and 12 months'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': '6 and 12 months'}, {'measure': 'Recurrent infarction', 'timeFrame': '30 days, 6 and 12 months'}, {'measure': 'Repeat revascularization (PCI or CABG)', 'timeFrame': '30 days, 6 and 12 months'}, {'measure': 'Status of Quality of life measured by EQ-5D-5L descriptive system', 'timeFrame': '12 months', 'description': 'The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems expressed by 1-digit-numbers ranging from 1 (extreme problems) to 5 (no problems). The toal score ranges from 0-15 where 15 is the worst score.'}, {'measure': 'Status of Quality of life measured by EQ VAS', 'timeFrame': '12 months', 'description': "The EuroQol Group visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the maximum 100 is labelled 'The best health you can imagine' and the minimum 0 is labelled 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction', 'Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '41114622', 'type': 'DERIVED', 'citation': 'Thevathasan T, Alyahoud M, Freund A, Akin I, Fichtlscherer S, Zeymer U, Feistritzer HJ, Poss J, Jobs A, Rossberg M, Jung C, Skurk C, Rassaf T, Ouarrak T, Schneider S, Thiele H, Desch S. Extracorporeal Membrane Oxygenation Complications Are Not Causal for Mortality in Patients With Infarct-Related Cardiogenic Shock: A Mediation Analysis of the Extracorporeal Life Support in Infarct-Related Cardiogenic Shock (ECLS-SHOCK) Trial. Crit Care Med. 2025 Dec 1;53(12):e2607-e2617. doi: 10.1097/CCM.0000000000006893. Epub 2025 Oct 17.'}, {'pmid': '40139846', 'type': 'DERIVED', 'citation': 'Feistritzer HJ, Zeymer U, Ouarrak T, Akin I, Rassaf T, Lehmann R, Eitel I, Seidler T, Skurk C, Clemmensen P, Voigt I, Seyfarth M, Linke A, Tigges E, Jung C, Lauten P, Poss J, Schneider S, Desch S, Freund A, Thiele H; ECLS-SHOCK Investigators. Different Mechanical Circulatory Support Strategies for Infarct-Related Cardiogenic Shock: A Subanalysis of the ECLS-SHOCK Trial. JACC Cardiovasc Interv. 2025 Mar 24;18(6):691-701. doi: 10.1016/j.jcin.2024.12.010.'}, {'pmid': '37634145', 'type': 'DERIVED', 'citation': 'Thiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, Lehmann R, Eitel I, Graf T, Seidler T, Schuster A, Skurk C, Duerschmied D, Clemmensen P, Hennersdorf M, Fichtlscherer S, Voigt I, Seyfarth M, John S, Ewen S, Linke A, Tigges E, Nordbeck P, Bruch L, Jung C, Franz J, Lauten P, Goslar T, Feistritzer HJ, Poss J, Kirchhof E, Ouarrak T, Schneider S, Desch S, Freund A; ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:\n* Planned revascularization (PCI or alternatively CABG)\n* Systolic blood pressure \\<90 mmHg \\>30 min or catecholamines required to maintain pressure \\>90 mmHg during Systole\n* 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\n* Arterial lactate \\>3 mmol/l\n* Informed consent\n\nExclusion Criteria:\n\n* Resuscitation \\>45 minutes\n* Mechanical cause of cardiogenic shock\n* Onset of shock \\>12 h\n* Severe peripheral artery disease with impossibility to insert ECLS cannulae\n* Age \\<18 years or age \\>75 years\n* Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)\n* Other severe concomitant disease with limited life expectancy \\<6 months\n* Pregnancy\n* Participation in another trial'}, 'identificationModule': {'nctId': 'NCT03637205', 'acronym': 'ECLS-SHOCK', 'briefTitle': 'Extracorporeal Life Support in Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Helios Health Institute GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HRC[045584]'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECLS', 'description': 'PCI (or CABG) plus medical treatment + ECLS', 'interventionNames': ['Procedure: ECLS insertion', 'Other: Revascularisation and optimal medical treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No ECLS', 'description': 'PCI (or CABG) plus medical treatment', 'interventionNames': ['Other: Revascularisation and optimal medical treatment']}], 'interventions': [{'name': 'ECLS insertion', 'type': 'PROCEDURE', 'description': 'After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. ECLS insertion should be performed preferably before revascularization', 'armGroupLabels': ['ECLS']}, {'name': 'Revascularisation and optimal medical treatment', 'type': 'OTHER', 'description': 'After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.', 'armGroupLabels': ['ECLS', 'No ECLS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '99438', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka GmbH', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '74177', 'city': 'Bad Friedrichshall', 'country': 'Germany', 'facility': 'SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald'}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik Forschungsgesellschaft mbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'BG Klinikum Unfallkrankenhaus Berlin gGmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln Klinik III für Innere Medizin', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'St-Johannes-Hospital Klinik für Innere Medizin I', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01062', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '99089', 'city': 'Erfurt', 'country': 'Germany', 'facility': 'Helios Klinikum Erfurt 3. 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Klink III - Kardiologie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '65929', 'city': 'Frankfurt Höchst', 'country': 'Germany', 'facility': 'Klinikum Frankfurt Höchst'}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Universitätsmedizin Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Kliniken Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '74078', 'city': 'Heilbronn', 'country': 'Germany', 'facility': 'SLK-Kliniken Heilbronn GmbH', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes Klinik für Innere Medizin III', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Uniklinikum Jena Klinik für Innere Medizin I', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '34125', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Klinikum Kassel GmbH', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '47805', 'city': 'Krefeld', 'country': 'Germany', 'facility': 'Helios Klinikum Krefeld', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'zip': '63225', 'city': 'Langen', 'country': 'Germany', 'facility': 'Asklepios Kliniken Langen-Seligenstadt GmbH', 'geoPoint': {'lat': 49.98955, 'lon': 8.66852}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universität Leipzig Klinik und Poliklinik für Kardiologie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum der Stadt Ludwigshafen gGmbH', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '41063', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Kliniken Mariahilf GmbH', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '72764', 'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Kreiskliniken Reutlingen GmbH', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitätsmedizin Rostock Zentrum für Innere Medizin', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '53721', 'city': 'Siegburg', 'country': 'Germany', 'facility': 'Helios Klinikum Siegburg', 'geoPoint': {'lat': 50.80019, 'lon': 7.20769}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '65199', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '71364', 'city': 'Winnenden', 'country': 'Germany', 'facility': 'Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie', 'geoPoint': {'lat': 48.87563, 'lon': 9.39819}}, {'zip': '42117', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Holger Thiele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Department of Cardiology, Heart Center Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Health Institute GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, {'name': 'IHF GmbH - Institut für Herzinfarktforschung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}