Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT02449460
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2015-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Epidemiology in Russian Federation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood serum plasma urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2015-05-18', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '10 years', 'description': 'all cause motality registered by official statistics'}], 'secondaryOutcomes': [{'measure': 'Stroke', 'timeFrame': '10 years', 'description': 'ischemic and heamorragic stroke'}, {'measure': 'Miocardial infarction', 'timeFrame': '10 years'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertension', 'epidemiology', 'glucose', 'body mass index', 'lipids', 'smoking', 'coronary artery disease', 'arterial stiffness', 'carotid ultrasound'], 'conditions': ['Hypertension', 'Coronary Artery Disease', 'Diabetes', 'Heart Failure', 'Smoking', 'Lifestyle']}, 'descriptionModule': {'briefSummary': 'The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.', 'detailedDescription': 'Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Random sample population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- informed consent\n\nExclusion Criteria:\n\nNo'}, 'identificationModule': {'nctId': 'NCT02449460', 'acronym': 'ESSE-RF', 'briefTitle': 'Cardiovascular Epidemiology in Russian Federation', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}, 'officialTitle': 'Multicenter Observational Study of Epidemiology of Cardiovascular Diseases and Risk Factors in Different Regions of Russian Federation', 'orgStudyIdInfo': {'id': 'AlmazovFCHBE-4'}}, 'contactsLocationsModule': {'locations': [{'city': 'Orenburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Roman Libis, Prof', 'role': 'CONTACT', 'email': 'libis@mail.ru', 'phone': '79111555524'}, {'name': 'Roman Libis, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orenburg Medical Academi', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'city': 'Samara', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Dmitry Duplyakov', 'role': 'CONTACT', 'email': 'dyplyakov@yahoo.com', 'phone': '79277297273'}, {'name': 'Dmitriy Duplyakov, prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samara Medical University', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'centralContacts': [{'name': 'Eugene V Shlyakhto, Prof', 'role': 'CONTACT', 'email': 'e.shlyakhto@almazovcentre.ru', 'phone': '78127023700'}, {'name': 'Sergey A Boytsov, Prof', 'role': 'CONTACT', 'email': 'profboytsov@mail.ru', 'phone': '74953641159'}], 'overallOfficials': [{'name': 'Svetlana A Shalnova, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'State Sientific Center of Preventive Medicine'}, {'name': 'Alexandra O Konradi, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}, {'name': 'Eugene I Chazov, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Russian Research and Production Complex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Center for Preventive Medicine', 'class': 'OTHER_GOV'}, {'name': 'Russian Cardiology Research and Production Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Conrady Alexandra', 'investigatorAffiliation': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}}}}