Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01633502
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Danish Cardiogenic Shock Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2012-06-29', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemodynamics', 'timeFrame': 'up to 7 days', 'description': 'Cardiac power index'}, {'measure': 'Hemodynamics', 'timeFrame': 'up to 7 days', 'description': 'Lactate clearence'}, {'measure': 'Hemodynamics', 'timeFrame': 'up to 7 days', 'description': 'Pulmonary artery pulsatility index'}, {'measure': 'Health economics', 'timeFrame': 'up to 6 months', 'description': 'Cost of treatments'}, {'measure': 'Renal function', 'timeFrame': 'up to 30 days', 'description': 'Development of acute kidney injury and need for dialysis'}, {'measure': 'Bleeding', 'timeFrame': 'up to 30 days', 'description': 'Bleeding complications during admission'}, {'measure': 'Revascularization strategy', 'timeFrame': 'During procedure', 'description': 'Syntax score ( a grading system that evaluates the complexity and prognosis of patients undergoing percutaneous coronary intervention, higher scores denotes more complex disase and higher risk)'}, {'measure': 'Revascularization strategy', 'timeFrame': 'up to 6 months', 'description': 'Additional non culprit revascularization'}], 'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'up to 6 months', 'description': 'Death from all causes'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': 'minimum follow-up 6 months', 'description': 'Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.'}, {'measure': 'Composite saftey', 'timeFrame': 'up to 6 months', 'description': 'Combined safety comprising major bleeding, vascular complications, and significant hemolysis.'}, {'measure': 'Days alive out of hospital', 'timeFrame': 'up tp 6 months', 'description': 'Days alive and out of hospital; calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiogenic Shock Acute', 'Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '36272450', 'type': 'BACKGROUND', '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.'}, {'pmid': '31176289', 'type': 'BACKGROUND', '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.'}, {'pmid': '38587239', 'type': 'RESULT', '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.'}, {'pmid': '41222528', 'type': 'DERIVED', 'citation': 'Mangner N, Beske RP, Hassager C, Jensen LO, Eiskjaer H, Linke A, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Engstrom T, Holmvang L, Lonborg JT, Udesen NLJ, Schmidt H, Junker A, Terkelsen CJ, Schrage B, Woitek FJ, Moller JE; DanGer Shock Investigators. Sex-Specific Microaxial Flow Pump Use and Outcomes in Infarct-Related Cardiogenic Shock in the DanGer Shock Trial. J Am Coll Cardiol. 2025 Oct 17:S0735-1097(25)07782-4. doi: 10.1016/j.jacc.2025.09.019. Online ahead of print.'}, {'pmid': '40884241', 'type': 'DERIVED', 'citation': 'Mikkelsen AD, Beske RP, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze C, Skurk C, Nordbeck P, Schrage B, Panoulas V, Zimmer S, Schafer A, Engstrom T, Holmvang L, Frydland M, Junker AB, Schmidt H, Udesen NLJ, Wachtell K, Terkelsen CJ, Linke A, Kjaergaard J, Moller JE, Hassager C; DanGer Shock Investigators. Systolic Blood Pressure and Microaxial Flow Pump-Associated Survival in Infarct-Related Cardiogenic Shock: A Post Hoc Analysis of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. 2025 Nov 1;10(11):1157-1165. doi: 10.1001/jamacardio.2025.3337.'}, {'pmid': '40562510', 'type': 'DERIVED', 'citation': 'Moller JE, Beske RP, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Schrage B, Panoulas V, Zimmer S, Schafer A, Werner N, Holmvang L, Kjaergaard J, Engstom T, Udesen NLJ, Schmidt H, Junker A, Wachtell K, Terkelsen CJ, Christensen S, Linke A, Burkhoff D, Hassager C; DanGer Shock Investigators. Effect of Microaxial Flow Pump on Hemodynamics in STEMI-Related Cardiogenic Shock. J Am Coll Cardiol. 2025 Jul 1;85(25):2456-2468. doi: 10.1016/j.jacc.2025.04.062.'}, {'pmid': '39551167', 'type': 'DERIVED', 'citation': 'Klein A, Beske RP, Hassager C, Jensen LO, Eiskjaer H, Mangner N, Linke A, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Engstom T, Holmvang L, Junker A, Schmidt H, Terkelsen CJ, Moller JE; DanGer Shock Investigators. Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous? J Am Coll Cardiol. 2025 Feb 18;85(6):595-603. doi: 10.1016/j.jacc.2024.11.003. Epub 2024 Nov 15.'}, {'pmid': '39462276', 'type': 'DERIVED', 'citation': 'Zweck E, Hassager C, Beske RP, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Kelm M, Engstrom T, Holmvang L, Junker A, Schmidt H, Terkelsen CJ, Linke A, Westenfeld R, Moller JE; DanGer Shock Investigators. Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial. Circulation. 2024 Dec 17;150(25):1990-2003. doi: 10.1161/CIRCULATIONAHA.124.072370. Epub 2024 Oct 27.'}, {'pmid': '39462240', 'type': 'DERIVED', 'citation': 'Udesen NLJ, Beske RP, Hassager C, 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, Engstom T, Schmidt H, Junker A, Terkelsen CJ, Christensen S, Linke A, Moller JE; DanGer Shock Investigators. Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):9-16. doi: 10.1001/jamacardio.2024.4197.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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\n2. Cardiogenic shock of less than 24 hours' duration, confirmed by:\n\n * peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 \\<55% with a normal PaO2) and\n * systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and\n3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \\>1,6.\n\nExclusion Criteria:\n\n1. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).\n2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).\n3. Severe aorta valve regurgitation/stenosis.\n4. Predominant right ventricular failure.\n5. Out of hospital cardiac arrest with persistent Glasgow coma scale \\<8 after return of spontaneous circulation.\n6. Shock duration\\>24 hours.\n7. Known heparin intolerance.\n8. Already established mechanical circulatory support\n9. Do not resuscitate wish."}, 'identificationModule': {'nctId': 'NCT01633502', 'acronym': 'DanShock', 'briefTitle': 'Danish Cardiogenic Shock Trial', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial', 'orgStudyIdInfo': {'id': 'DanShock-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional circulatory support', 'description': 'Patients randomized to conventional circulatory support.', 'interventionNames': ['Device: Conventional circulatory support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Impella', 'description': 'Patients randomized to Impella CP', 'interventionNames': ['Device: Impella CP']}], 'interventions': [{'name': 'Conventional circulatory support', 'type': 'DEVICE', 'otherNames': ['Conventional circulatory support will be employed according to enrolling sites usual management.'], 'description': 'Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.', 'armGroupLabels': ['Conventional circulatory support']}, {'name': 'Impella CP', 'type': 'DEVICE', 'otherNames': ['Impella CP, Abiomed'], 'description': 'Control group treated with Impella CP for a minimum of 48 hrs.', 'armGroupLabels': ['Impella']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'DK-5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Dresden University Hospital', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Düsseldorf University Hospital', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Trier', 'country': 'Germany', 'facility': 'Brüderkrankenhaus Trier', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'NHs Harefield Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jacob E Moller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Odense University Hospital, Odense'}, {'name': 'Anders Junker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiology, Odense University Hospital'}, {'name': 'Christian Hassager, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiology, Copenhagen University Hospital Gentofte'}, {'name': 'Andreas Shaefer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hannover Medical School'}, {'name': 'Nikos Werner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Trier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital Skejby', 'class': 'OTHER'}, {'name': 'Hannover Medical School', 'class': 'OTHER'}, {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, {'name': 'Jena University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital Dresden', 'class': 'OTHER'}, {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Cardiology', 'investigatorFullName': 'Jacob Moller', 'investigatorAffiliation': 'Odense University Hospital'}}}}