Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 7:27 AM
Study NCT ID:
NCT02544594
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular ejection fraction (LVEF) on day 30', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days'}, {'measure': 'Lactate levels', 'timeFrame': 'up to 48 hours'}, {'measure': 'potentia hydrogenic levels', 'timeFrame': '48 hours'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': '30 days'}, {'measure': 'Long-term mortality at 12 months', 'timeFrame': 'up to 12 months'}, {'measure': 'Length of ICU stay', 'timeFrame': '30 days'}, {'measure': 'Neurological Outcome (modified Rankin Scale)', 'timeFrame': 'up to 12 months'}, {'measure': 'MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI)', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '31072581', 'type': 'DERIVED', 'citation': 'Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.', 'detailedDescription': 'Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function.\n\nThis study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.\n\nThe main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with\n\n* intended revascularization (PCI or CABG)\n* Systolic blood pressure \\< 90 mmHg \\> 30 min or inotropes required to maintain pressure \\> 90 mmHg during systole\n* Signs of left heart insufficiency and pulmonary congestion\n* Signs of impaired organ perfusion with at least one of the following:\n\n * Altered mental status\n * Cold, clammy skin\n * Urine output \\<30 ml/h\n * Serum lactate \\>2mmol/l\n* Informed consent\n\nExclusion Criteria:\n\n* Resuscitation \\> 60 minutes, ischemia \\> 10 minutes\n* No intrinsic heart action\n* Cerebral deficit with fixed dilated pupils\n* Mechanical infarction complication\n* Onset of shock \\> 12 h\n* Severe peripheral artery disease\n* Aortic regurgitation \\> II.°\n* Age \\> 80 years\n* shock of other cause\n* Other severe concomitant disease\n* participation in another trial'}, 'identificationModule': {'nctId': 'NCT02544594', 'acronym': 'ECLS-SHOCK', 'briefTitle': 'Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'GE IDE MucM001-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extra-Corporal Life Support (ECLS)', 'description': 'Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction.', 'interventionNames': ['Device: Extra-Corporal Life Support (ECLS)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard treatment', 'description': 'Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction.'}], 'interventions': [{'name': 'Extra-Corporal Life Support (ECLS)', 'type': 'DEVICE', 'description': 'Extra-Corporal Life Support (ECLS) (from Sorin)', 'armGroupLabels': ['Extra-Corporal Life Support (ECLS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Stefan Brunner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Munich University Hospital'}, {'name': 'Steffen Massberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Munich University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'PD Dr. Stefan Brunner', 'investigatorAffiliation': 'LMU Klinikum'}}}}