Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 5:03 PM
Study NCT ID:
NCT05465200
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2022-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Silesia Cardiogenic Shock Initiative
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-days all-cause mortality', 'timeFrame': '30 days', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': '12-months mortality', 'timeFrame': '12 months', 'description': 'All-cause mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiogenic shock', 'ECMO', 'Heart transplant', 'Mechanical circulatory support', 'Impella'], 'conditions': ['Cardiogenic Shock']}, 'descriptionModule': {'briefSummary': 'LSCSI is a Hub\\&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one "hub" which is Wroclaw University Hospital and eleven "spokes" which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the "hub" for enhanced treatment options including durable mechanical circulatory support or heart transplant. The "hub" have 7/24 Shock Team on-site supplied with a protocol how to proceed with "spoke" transferred patients including decision making on which mechanical circulatory support implant with subsequent de-escalation or escalation pathway.', 'detailedDescription': 'LSCSI is a Hub\\&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one "hub" which is Wroclaw University Hospital and eleven "spokes" which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the "hub" for enhanced treatment options including durable mechanical circulatory support or heart transplant.\n\nShared cardiogenic shock definition:\n\n1. Systolic blood pressure \\< 90 mmHg for \\> 30 minutes or need for vasopressors use to maintain systolic blood pressure \\> 90 mmHg\n2. Lactate level \\> 2.0 mmol/L\n3. Pulmonary capillary wedge pressure or left ventricle end diastolic pressure \\> 15 mmHg (excluding pulmonary embolism)\n4. Cardiac Index ≤ 2.2 l/min/m2\n5. Diuresis \\< 30 ml/h\n6. Clinical signs of peripheral hypoperfusion\n\nData required by "hub" from "spoke"\n\n1. Echocardiography with data on left and right ventricle function\n2. Current aortic and mixed venous blood gases\n3. Pulmonary artery catheter measurements including calculation of cardiac power, pulmonary artery pulsatile index, cardiac output, cardiac index, pulmonary artery wedge pressure, pulmonary vascular resistance, systemic vascular resistance (excluding pulmonary embolism)\n4. Peripheral blood tests including liver and kidney function, morphology, troponin, natriuretic peptides\n5. Currently used and possible for use vascular accesses\n6. For pulmonary embolism: computed tomography of pulmonary arteries\n\nUpon telephone contact "hub" shock team decides on patients transfer or further treatment in "spoke" facility. When decision on transfer is taken shock team members gather at emergency room when patient arrives and decides on treatment options according to shock team protocol. As a "hub" Wroclaw University Hospital provides mechanical circulatory support (Intra-aortic balloon pump, Impella CP (Cardiac Power), Impella 5.0, Impella RP (Right Pump), ECMO (ExtraCorporeal Membrane Oxygenation), Levitronix, HeartMate3) together with heart transplant program as a regional reference center for advanced heart failure patients. Additionally for acute pulmonary embolism complicated by shock "hub" provides peripheral or local thrombolysis and in case of contraindication for thrombolysis - transcatheter thrombectomy or surgical embolectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'LSCSI is designed to treat cardiogenic shock which may develop during:\n\n1. Acute coronary syndrome\n2. Acute decompensated heart failure\n3. Acute myocarditis\n4. Acute or decompensated chronic valvular heart disease\n5. Takotsubo cardiomyopathy\n6. Peripartum cardiomyopathy\n7. Acute pulmonary embolism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fulfilled definition of cardiogenic shock\n2. Age 18 - 60 years\n3. Shock duration below 24 hours\n\nExclusion Criteria:\n\n1. History of cardiac arrest with anoxemic brain injury\n2. Irreversible multiorgan failure\n3. End stage of chronic diseases other than heart failure\n4. Neoplastic disease\n5. Lack of vascular access'}, 'identificationModule': {'nctId': 'NCT05465200', 'acronym': 'LSCSI', 'briefTitle': 'Lower Silesia Cardiogenic Shock Initiative', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland', 'orgStudyIdInfo': {'id': 'WMU012021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Structured treatment of cardiogenic shock patients', 'type': 'PROCEDURE', 'description': 'Creation of hub\\&spoke structure which covers all Lower Silesian Voivodeship (Poland) for treatment of cardiogenic shock patients. Based on shared protocol patients are reported to "hub" by "spoke" and decision is made as for patient transfer or further treatment in the "spoke" facility. If decision on transfer is made, patient is further treated according to "hub" on site shock team protocol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-556', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Wiktor Kuliczkowski, MD PD', 'role': 'CONTACT', 'email': 'wiktor.kuliczkowski@umed.wroc.pl', 'phone': '+48717331112'}, {'name': 'Mateusz Sokolski, MD PhD', 'role': 'CONTACT', 'email': 'mateusz.sokolski@umed.wroc.pl', 'phone': '+48717331112'}, {'name': 'Wiktor Kuliczkowski, MD PD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mateusz Sokolski, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Heart Disease of Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Wiktor Kuliczkowski', 'role': 'CONTACT', 'email': 'wiktor.kuliczkowski@umed.wroc.pl', 'phone': '+48717331112'}, {'name': 'Mateusz Sokolski', 'role': 'CONTACT', 'email': 'mateusz.sokolski@umed.wroc.pl', 'phone': '+48717331112'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Catheterization Laboratory', 'investigatorFullName': 'Wiktor Kuliczkowski', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}