Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-03-09 @ 9:28 AM
Study NCT ID:
NCT06627933
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding', 'timeFrame': '1 month', 'description': 'All the cases of major and minor bleeding within 1 month'}, {'measure': 'Bleeding', 'timeFrame': '3 months', 'description': 'All the cases of major and minor bleeding within 3 months'}, {'measure': 'Bleeding', 'timeFrame': '6 months', 'description': 'All the cases of major and minor bleeding within 6 months'}, {'measure': 'Thromboembolism', 'timeFrame': '1 month', 'description': 'All the cases of venous thromboembolism within 1 month'}, {'measure': 'Thromboembolism', 'timeFrame': '3 months', 'description': 'All the cases of venous thromboembolism within 3 months'}, {'measure': 'Thromboembolism', 'timeFrame': '6 months', 'description': 'All the cases of venous thromboembolism within 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['joint replacement', 'prognosis', 'anticoagulation regimen', 'thromboembolism', 'venous thromboembolism'], 'conditions': ['Thromboembolism', 'Anticoagulant-induced Bleeding']}, 'referencesModule': {'references': [{'pmid': '38158917', 'type': 'BACKGROUND', 'citation': 'Okisheva EA, Mironova OI, Berdysheva MV, Pyatigorets ES, Krivova NP, Kurnosova AA, Elizarov MP, Smetanin SM, Lychagin AV, Fomin VV. [Relationship between the pain severity, use of non-steroidal anti-inflammatory drugs and blood pressure in elective large joint arthroplasty of the lower extremities]. Ter Arkh. 2023 Nov 3;95(9):751-756. doi: 10.26442/00403660.2023.09.202373. Russian.'}, {'pmid': '39106508', 'type': 'RESULT', 'citation': 'Okisheva EA, Trushina OY, Mamaeva MM, Redyanova EA, Zhazhieva AA, Chasova ID, Panferov AS, Bogdanov MM, Lychagin AV, Fomin VV. [Glucose metabolism disorders and hypoglycemic therapy in patients hospitalized for elective lower limb arthroplasty: a prospective, single-center, real-world study]. Ter Arkh. 2024 Jul 30;96(7):659-665. doi: 10.26442/00403660.2024.07.202780. Russian.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to evaluate the frequency of cardiovascular and thromboembolic complications in patients with cardiovascular disease after lower limb joint replacement, the influence of known risk factors and strategies for perioperative prevention of thromboembolic complications on the frequency of cardiovascular complications and to develop approaches to optimize antithrombotic prevention tactics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is planned to include 1,000 patients with cardiovascular diseases who undergo routine endoprosthetics of large joints of the lower extremities. During the follow-up, patients will be divided into subgroups depending on the scheme of perioperative prevention of thromboembolic complications and the presence of risk factors. The comparison will be carried out in the appropriate subgroups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Age older than 18 y.o.\n* Cardiovascular disease\n* Indications for planned lower limb joint replacement surgery\n\nExclusion Criteria:\n\n* Pregnancy\n* Psychiatric disorders\n* Decompensated heart failure or acute heart failure\n* Known diagnosis of cancer'}, 'identificationModule': {'nctId': 'NCT06627933', 'briefTitle': 'Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement', 'orgStudyIdInfo': {'id': '11-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low thromboembolic risk'}, {'label': 'Moderate thromboembolic risk'}, {'label': 'High thromboembolic risk', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['High thromboembolic risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119991', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Okisheva, MD, PhD', 'role': 'CONTACT', 'email': 'e.okisheva@gmail.com', 'phone': '+79161162393'}, {'name': 'Elena Okisheva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital #1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Elena Okisheva, MD, PhD', 'role': 'CONTACT', 'email': 'e.okisheva@gmail.com', 'phone': '+79161162393'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Olga Trushina', 'investigatorAffiliation': 'I.M. Sechenov First Moscow State Medical University'}}}}