Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 2:39 PM
Study NCT ID:
NCT04546750
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2020-09-05', 'studyFirstSubmitQcDate': '2020-09-05', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of primary varicose veins', 'timeFrame': '1 year', 'description': 'Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)'}], 'secondaryOutcomes': [{'measure': 'Progression of primary varicose veins', 'timeFrame': '1 year', 'description': 'The presence of varicose veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)'}, {'measure': 'Incidence of chronic venous insufficiency', 'timeFrame': '1 year', 'description': 'Number of participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)'}, {'measure': 'Incidence of superficial vein thrombosis', 'timeFrame': '1 year', 'description': 'Number of participants with first episode of superficial vein thrombosis'}, {'measure': 'Incidence of reticular and telangiectatic leg veins', 'timeFrame': '1 year', 'description': 'Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)'}, {'measure': 'Progression of reticular and telangiectatic leg veins', 'timeFrame': '1 year', 'description': 'The presence of reticular and telangiectatic leg veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicose Veins of Lower Limb', 'Thromboses, Venous', 'Venous Insufficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://epid.venousregistry.org/', 'label': 'The accumulation of data will be carried out on the basis of an termless Russian epidemiological registry, ClinicalTrials.gov Identifier: NCT04487314'}]}, 'descriptionModule': {'briefSummary': 'A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course of chronic lower limb vein disease.', 'detailedDescription': 'Multicenter prospective cohort observational study based on a termless epidemiological registry. Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year. Patient data is recorded in a digital database and is constantly updated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The main cohort is formed from those who do not have varicose veins, who are affected by different factors that we register (various physical activities, the presence or absence of pregnancy, etc.).\n\nAn additional cohort is formed from those who have varicose veins at the time of inclusion.\n\nThe goal is to track the natural evolution (progression) of the disease, to evaluate the incidence and risk factors of complications.\n\nAn extremely important criterion for the formation of the study population is the possibility to control the lower legs veins of observed individuals by a qualified vascular specialist. To date, a qualitative assessment of veins according to the CEAP classification is a weak point in longitudinal epidemiological studies.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself\n* The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals\n\nExclusion Criteria:\n\n* Any invasive treatment of the chronic venous disorder in anamnesis\n* Venous thrombosis in the anamnesis or at the time of inclusion'}, 'identificationModule': {'nctId': 'NCT04546750', 'acronym': 'VINCI', 'briefTitle': 'Prospective Cohort Study for Varicose Veins Incidence and Natural Course', 'organization': {'class': 'OTHER', 'fullName': 'Russian Phlebological Association'}, 'officialTitle': 'Prospective Cohort Study for Varicose Veins Incidence and Natural Course', 'orgStudyIdInfo': {'id': 'RPA 7.001.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without Varicose Veins', 'description': 'Individuals who do not have varicose veins of lower legs: C0, C1 classes according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)'}, {'label': 'Patients with Varicose Veins', 'description': 'Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '197350', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Evgeny Ilyukhin, PhD', 'role': 'CONTACT', 'email': 'eugen.iluhin@gmail.com'}], 'facility': '"Medalp" private surgery clinic', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Igor Zolotukhin, MD, PhD', 'role': 'CONTACT', 'email': 'zoloto70@bk.ru', 'phone': '+79255182479'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Phlebological Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}