Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-25 @ 3:01 AM
Study NCT ID:
NCT05575856
Status:
UNKNOWN
Last Update Posted:
2022-10-12
First Post:
2022-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiogenic Shock Registry Mannheim
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012769', 'term': 'Shock'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-03-12', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '30 days', 'description': 'days'}], 'secondaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': 'during hospital stay (up to 30 days)', 'description': 'during hospital stay (up to 30 days)'}, {'measure': 'all-cause mortality', 'timeFrame': '1 years', 'description': 'years'}, {'measure': 'ventilator-free days', 'timeFrame': '30 days', 'description': 'days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiogenic shock', 'heart failure', 'cardiac arrest', 'shock', 'acute myocardial infarction'], 'conditions': ['Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '39618866', 'type': 'DERIVED', 'citation': 'Rusnak J, Schupp T, Weidner K, Ruka M, Egner-Walter S, Schmitt A, Akin M, Tajti P, Mashayekhi K, Ayoub M, Behnes M, Akin I. Prognostic Influence of Lung Compliance in Patients with Cardiogenic Shock and Invasive Mechanical Ventilation. Rev Cardiovasc Med. 2024 Nov 22;25(11):420. doi: 10.31083/j.rcm2511420. eCollection 2024 Nov.'}, {'pmid': '39470337', 'type': 'DERIVED', 'citation': 'Rusnak J, Schupp T, Weidner K, Ruka M, Egner-Walter S, Forner J, Schmitt A, Akin M, Tajti P, Mashayekhi K, Ayoub M, Akin I, Behnes M. Influence of Right and Left Bundle Branch Block in Patients With Cardiogenic Shock and Cardiac Arrest. Crit Care Med. 2025 Jan 1;53(1):e54-e64. doi: 10.1097/CCM.0000000000006459. Epub 2024 Oct 29.'}, {'pmid': '37831815', 'type': 'DERIVED', 'citation': 'Schupp T, Rusnak J, Forner J, Dudda J, Bertsch T, Behnes M, Akin I. Platelet Count During Course of Cardiogenic Shock. ASAIO J. 2024 Jan 1;70(1):44-52. doi: 10.1097/MAT.0000000000002066. Epub 2023 Oct 12.'}, {'pmid': '37579943', 'type': 'DERIVED', 'citation': 'Behnes M, Rusnak J, Egner-Walter S, Ruka M, Dudda J, Schmitt A, Forner J, Mashayekhi K, Tajti P, Ayoub M, Weiss C, Akin I, Schupp T. Effect of Admission and Onset Time on the Prognosis of Patients With Cardiogenic Shock. Chest. 2024 Jan;165(1):110-127. doi: 10.1016/j.chest.2023.08.011. Epub 2023 Aug 12.'}, {'pmid': '37004944', 'type': 'DERIVED', 'citation': 'Schmitt A, Schupp T, Rusnak J, Ruka M, Egner-Walter S, Mashayekhi K, Tajti P, Ayoub M, Behnes M, Akin I, Weidner K. Does sex affect the risk of 30-day all-cause mortality in cardiogenic shock? Int J Cardiol. 2023 Jun 15;381:105-111. doi: 10.1016/j.ijcard.2023.03.061. Epub 2023 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register.', 'detailedDescription': "All consecutive patients with a confirmed cardiogenic shock presenting at the internal intensive care Unit (ICU) at the University of Mannheim are included in the register and followed up during ICU stay and after that. Data of patients' admission status, cause of cardiogenic shock, baseline parameters and comorbidities are collected. Extensive information about echocardiography, electrocardiography and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2, 3, 5, 7, and 8). Standard scores for critically ill patients were calculated for the day of admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality and 1-year mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes all patients presenting with a cardiogenic shock at the intensive care unit (ICU).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiogenic shock according to current guidelines\n\nExclusion Criteria:\n\n* other forms of shock not primary associated with cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT05575856', 'acronym': 'CARESMA', 'briefTitle': 'Cardiogenic Shock Registry Mannheim', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Cardiogenic Shock Registry Mannheim - CARESMA', 'orgStudyIdInfo': {'id': '2019-695N'}}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ibrahim Akin, MD, PhD', 'role': 'CONTACT', 'email': 'ibrahim.akin@umm.de', 'phone': '0049621-3836239'}, {'name': 'Michael Behnes, MD, PhD', 'role': 'CONTACT', 'email': 'michael.behnes@umm.de', 'phone': '0049621-3836239'}, {'name': 'Jonas Rusnak, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Department of Medicine, University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Michael Behnes, PhD', 'role': 'CONTACT', 'email': 'michael.behnes@umm.de', 'phone': '0049621-3836239'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Michael Behnes', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}