Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-20 @ 2:12 AM
Study NCT ID:
NCT06697093
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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': 500}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': 'From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months', 'description': 'all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'myocardial infarction', 'timeFrame': 'From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months', 'description': 'Recurrent myocardial infarction following an initial event'}, {'measure': 'stroke', 'timeFrame': 'From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months', 'description': 'stroke following an initial event'}, {'measure': 'heart transplantation', 'timeFrame': 'From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months', 'description': 'Heart transplantation in patients without myocardial recovery following cardiogenic shock.'}, {'measure': 'long-term LVAD implantation', 'timeFrame': 'From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months', 'description': 'Long-term LVAD implantation in patients without myocardial recovery following cardiogenic shock'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical circulatory support', 'myocardial infarction', 'Cardiogenic shock'], 'conditions': ['Cardiogenic Shock']}, 'descriptionModule': {'briefSummary': 'The registry objective is to get information on current epidemiology, diagnostics, treatment and outcome in patients with cardiogenic shock in Poland. Obtained information will help to plan the nationwide initiative for modern cardiogenic shock treatment with established place for mechanical circulatory support.\n\nIt is hypothesized that the treatment and outcome of cardiogenic shock, including mechanical circulatory support, are currently poor in Poland and should be improved. Unfortunately, without status quo data, efficient planning for its improvement cannot be conducted, hence the CaS-POL registry initiative.', 'detailedDescription': 'The prospective registry will be open in nature; any cardiology department in Poland with access to a 24-hour hemodynamic laboratory will be eligible to participate in the study. All participants will use an electronic CRF (Case Report Form) to anonymously collect data on the incidence, etiology, diagnosis, treatment approaches, and prognosis of patients with cardiogenic shock. Data will be collected by researchers from the medical documentation of participating centers. The data collection period will span six months, followed by a six-month prospective observation through visit in person, per telephone contact to the patient or his/her relatives or by retracting National Health Fund data in case the contact to the patient or his/her relatives is impossible.\n\nTo enable comparison with global data, collected information will include, among other aspects, the latest Society for Cardiovascular Angiography and Interventions (SCAI) classification for cardiogenic shock, the availability and application of modern short- and long-term mechanical circulatory support techniques, and the frequency of heart transplants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the Intensive Care Unit (ICU) in the Cardiology, Cardiac Surgery, or to the Anesthesiology departments with a clinically evident cardiac etiology of shock.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiogenic shock patients of all etiologies in SCAI stage B, C, D, E.\n* age \\> 18 years old\n* persistent hemodynamic failure defined as systolic blood pressure of \\<90 mmHg for ≥ 30 minutes or the requirement for inotropic or vasopressor agents with evidence of hypoperfusion of the peripheral organs\n\nExclusion Criteria:\n\n* patients without return of spontaneous circulation who were considered to extracorporeal cardiopulmonary resuscitation (ECPR)\n* primary septic, anaphylactic, hypovolemic shock\n* post-operative cardiogenic shock\n* end-stage of heart failure disqualified from mechanical circulatory support and heart transplantation'}, 'identificationModule': {'nctId': 'NCT06697093', 'acronym': 'CaS-POL', 'briefTitle': 'Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL', 'orgStudyIdInfo': {'id': 'KB/16/2023/N'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cardiogenic shock patients', 'description': 'The registry will include all patients presenting with primary cardiogenic shock. All medical interventions will be conducted based on established clinical indications.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-556', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Wiktor Kuliczkowski, MD, PhD', 'role': 'CONTACT', 'email': 'wiktor.kuliczkowski@umw.edu.pl', 'phone': '+48 71 736 42 51'}], 'facility': 'Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '50-556', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maja Pekala', 'role': 'CONTACT', 'email': 'm.pekala@umw.edu.pl', 'phone': '+48717840697'}], 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Wiktor Kuliczkowski, MD,PhD', 'role': 'CONTACT', 'email': 'wiktor.kuliczkowski@umw.edu.pl', 'phone': '+48 71 736 42 51'}, {'name': 'Mikołaj Błaziak, MD', 'role': 'CONTACT', 'email': 'blaziak.mikolaj@gmail.com', 'phone': '+48 71 736 42 51'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Polish Cardiac Society', 'class': 'OTHER'}, {'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor, Head of the Catheterization Laboratory at Wroclaw University Hospital', 'investigatorFullName': 'Wiktor Kuliczkowski', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}