Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-10 @ 6:18 PM
Study NCT ID:
NCT02743533
Status:
UNKNOWN
Last Update Posted:
2017-04-25
First Post:
2016-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Diseases in the Silesian Region in Poland.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with reported deaths from any cause', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Trends in the number of hospitalization due to cardiovascular diseases', 'timeFrame': '1 year'}, {'measure': 'Trends in the number of diagnostic and therapeutic procedures', 'timeFrame': '1 year'}, {'measure': 'Number of participants with reported rehospitalization', 'timeFrame': 'From date of inclusion until the date of first event, assessed up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular diseases, prognosis'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '33926171', 'type': 'DERIVED', 'citation': 'Myrda K, Blachut A, Buchta P, Skrzypek M, Wnuk-Wojnar AM, Hoffmann A, Nowak S, Kowalski O, Pruszkowska P, Sokal A, Wita K, Mizia-Stec K, Gasior M, Kalarus Z. Impact of the coronavirus disease 2019 pandemic on atrial fibrillation and atrial flutter ablation rates. The analysis of nearly 5 million Polish population. Kardiol Pol. 2021;79(6):687-689. doi: 10.33963/KP.15988. Epub 2021 May 20. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The Silesian Cardiovascular Database is an observational study of all patients hospitalized due to cardiovascular diseases. The date include information on the clinical characteristics, treatment modalities and prognosis in this population.\n\nThe data include information on all the applicable diagnostic and therapeutic procedures, prognosis and hospitalization costs. Likewise, data have been collected specialist care outpatient visits and primary health care patients were hospitalized.', 'detailedDescription': 'The Silesian Cardiovascular Database is an prospective observational study patients who were hospitalized in the Silesian region in Poland due to cardiovascular diseases from 1st January 2006.\n\nThe aim of the study is to collect and analyze all epidemiological data, diagnostic and therapeutic procedures, in-hospital and long-term prognosis, hospitalization costs of these patients. Likewise, data have been collected specialist care outpatient visits and primary health care patients were hospitalized.\n\nFor the analysis were included patients hospitalized in the cardiology, cardiac surgery , diabetes, vascular surgery wards and who were hospitalized for cardiac diagnosis in the wards of internal medicine and intensive care.\n\nThe Silesian Cardiovascular Database was created based on the agreement between Silesian Centre for Heart Diseases in Zabrze and the Regional Department of National Health Fund in Katowice in order to conduct analyses and prepare scientific elaborations on the group of patients with circulatory system diseases. Data elaboration and preparation for analyses was conducted by the Science Department of Silesian Centre for Heart Diseases and the Department of Biostatistics of Medical University of Silesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is formed by all patients hospitalized in the Silesian region in Poland due to cardiovascular diseases from 1st January 2006.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* each hospitalisation in the departments of: cardiology, cardiac surgery, diabetology and vascular surgery,\n* hospitalisation with cardiological diagnosis in the departments of internal medicine and intensive care.\n\nExclusion Criteria:\n\n* hospitalisations of patients from beyond Silesia Province,\n* patients at the age below18 years at the moment of admission to the hospital'}, 'identificationModule': {'nctId': 'NCT02743533', 'acronym': 'SILICARD', 'briefTitle': 'Cardiovascular Diseases in the Silesian Region in Poland.', 'organization': {'class': 'OTHER', 'fullName': 'Silesian Centre for Heart Diseases'}, 'officialTitle': 'Trends in the Incidence, Treatment and Prognosis of Cardiovascular Diseases in the Silesian Region in Poland. SILesIan CARdiovascular Database (SILICARD)', 'orgStudyIdInfo': {'id': 'SCD016'}}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Damian Pres, M.D.', 'role': 'CONTACT', 'email': 'damianpres@wp.pl', 'phone': '+48667288320'}], 'facility': 'Silesian Center for Heart Diseases', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'centralContacts': [{'name': 'Damian Pres, MD', 'role': 'CONTACT', 'email': 'damianpres@wp.pl', 'phone': '48667288320'}], 'overallOfficials': [{'name': 'Mariusz Gasior, Prof., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases, Zabrze, Poland'}, {'name': 'Damian Pres, MD', 'role': 'STUDY_CHAIR', 'affiliation': '3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases, Zabrze, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silesian Centre for Heart Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Mariusz Gasior', 'investigatorAffiliation': 'Silesian Centre for Heart Diseases'}}}}