Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04527367
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2020-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiology and Long-term Outcome of Patients With VHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D008946', 'term': 'Mitral Valve Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2020-08-22', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '3665 days', 'description': 'All-cause of mortality'}], 'secondaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '3665 days', 'description': 'Mocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Valvular Heart Disease', 'Aortic Valve Stenosis', 'Mitral Insufficiency', 'Coronary Artery Disease', 'Chronic Kidney Diseases'], 'conditions': ['Valvular Disease', 'Valvular Heart Disease', 'Aortic Valve Stenosis', 'Mitral Insufficiency and Aortic Stenosis', 'Mitral Stenosis', 'Coronary Artery Disease', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '31933658', 'type': 'RESULT', 'citation': 'Kuzma L, Bachorzewska-Gajewska H, Kozuch M, Struniawski K, Pogorzelski S, Hirnle T, Dobrzycki S. Acute coronary syndromes and atherosclerotic plaque burden distribution in coronary arteries among patients with valvular heart disease (BIA-WAD registry). Postepy Kardiol Interwencyjnej. 2019;15(4):422-430. doi: 10.5114/aic.2019.90216. Epub 2019 Dec 8.'}, {'pmid': '32661631', 'type': 'RESULT', 'citation': 'Kuzma L, Malyszko J, Bachorzewska-Gajewska H, Niwinska MM, Kurasz A, Zalewska-Adamiec M, Kozuch M, Dobrzycki S. Impact of chronic kidney disease on long-term outcome of patients with valvular heart defects. Int Urol Nephrol. 2020 Nov;52(11):2161-2170. doi: 10.1007/s11255-020-02561-4. Epub 2020 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.', 'detailedDescription': 'Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy.\n\nPatients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in Medical University of Bialystok.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Valvular heart disease in moderate and severe stages\n\nExclusion Criteria:\n\n* Age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT04527367', 'acronym': 'BIA-WAD', 'briefTitle': 'Epidemiology and Long-term Outcome of Patients With VHD', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Bialystok'}, 'officialTitle': 'Epidemiology and Long-term Prognosis of Patients With Valvular Heart Diseases (BIA-WAD Study)', 'orgStudyIdInfo': {'id': 'UMB-KKI-101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VHD patients', 'description': 'Patients with moderate and severe valvular heart diseases', 'interventionNames': ['Procedure: Innovative medical technologies in invasive cardiology and cardiac surgery']}], 'interventions': [{'name': 'Innovative medical technologies in invasive cardiology and cardiac surgery', 'type': 'PROCEDURE', 'otherNames': ['Percutaneous coronary intervention', 'Percutaneous aortic valve replacement', 'Percutaneous interventional mitral regurgitation treatment', 'Cardiosurgery'], 'description': 'A follow-up study included the analysis of medical documentation of the Cardiosurgery and the Invasive Cardiology Departments to provided information on the duration and type of procedure performed.', 'armGroupLabels': ['VHD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}], 'overallOfficials': [{'name': 'Łukasz Kuźma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Bialystok'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Bialystok', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator,', 'investigatorFullName': 'Lukasz Kuzma', 'investigatorAffiliation': 'Medical University of Bialystok'}}}}