Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT03900234
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2019-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Chronic Venous Disease in General Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 783}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of chronic venous disease', 'timeFrame': 'up to Sept. 2015', 'description': 'As a disease positive subjects with any morphological and functional abnormalities of the venous system of long duration manifested either by symptoms and/or signs indicating the need for investigation and/or care will be considered'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic venous disease', 'prevalence', 'risk factors'], 'conditions': ['Chronic Venous Insufficiency']}, 'referencesModule': {'references': [{'pmid': '30958033', 'type': 'DERIVED', 'citation': 'Zolotukhin IA, Seliverstov EI, Shevtsov YN, Avakiants IP, Tatarintsev AM, Kirienko AI. Risk factors for venous symptoms in Russian patients with chronic venous disease. Curr Med Res Opin. 2019 Sep;35(9):1583-1587. doi: 10.1080/03007995.2019.1605050. Epub 2019 May 13.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to find prevalence and risk factors for chronic venous disease (CVD) in the general population. All the resident, who live in a single rural settlement will be invited to participate.', 'detailedDescription': 'The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study.\n\nThose who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered.\n\nSigns and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the residents of 10 years and more living in the same settlement, willing to participate will be included', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents living in the rural settlement where study will be conducted\n* both female and male\n* age 10 years and more\n* agree to participate\n* signed infromed consent\n\nExclusion Criteria:\n\n* age 9 years and less\n* not signed informed consent'}, 'identificationModule': {'nctId': 'NCT03900234', 'briefTitle': 'Prevalence of Chronic Venous Disease in General Population', 'organization': {'class': 'OTHER', 'fullName': 'Pirogov Russian National Research Medical University'}, 'officialTitle': 'Cross-Sectional Population Based Study on Prevalence and Risk Factors for Chronic Venous Disease in General Population', 'orgStudyIdInfo': {'id': '15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Residents of the single rural settlement', 'description': 'No interventions will be administered', 'interventionNames': ['Other: No intervention will be administered']}], 'interventions': [{'name': 'No intervention will be administered', 'type': 'OTHER', 'description': 'No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.', 'armGroupLabels': ['Residents of the single rural settlement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '117997', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Pirogov Russian National Research Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Igor Zolotukhin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Russian National Research Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD are going to be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Igor Zolotukhin', 'investigatorAffiliation': 'Pirogov Russian National Research Medical University'}}}}