Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT06812767
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-06
First Post:
2025-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors at Chronic Non-communicable Diseases in People of Working Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073296', 'term': 'Noncommunicable Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D018476', 'term': 'Hypokinesia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System 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'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2025-02-01', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of NCDs risk factors', 'timeFrame': 'on enrollment', 'description': 'risk factors of NCDs based on survey results and diagnostic tests'}, {'measure': 'prevalence of NCDs', 'timeFrame': 'on enrollment', 'description': 'diagnosed NCDs based on survey results, and diagnostic tests'}], 'secondaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': 'on enrollment', 'description': 'Urgent or emergent hospitalization during the visit if indicated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arterial hypertension', 'coronary heart disease', 'cerebrovascular disease', 'malignant tumors', 'chronic obstructive pulmonary disease', 'asthma', 'diabetes mellitus', 'environment', 'smoking', 'alcohol consumption', 'unbalanced diet', 'hypodynamia', 'obesity', 'overweight', 'dyslipidemia', 'hyperglycemia', 'microalbuminuria'], 'conditions': ['Chronic Non-communicable Disease']}, 'descriptionModule': {'briefSummary': 'Objectives: to study the clinical and demographic characteristics of working age persons, to highlight the main factors of non-communicable diseases (NCDs), to identify NCDs with physical examination, laboratory tests, electrocardiography and ultrasound imaging, to develop a corporate prevention program for the company to reduce the risk of complications of NCDs.\n\nResearch stages:\n\n1. Questionnaire to identify socio-demographic, behavioral, hereditary, psycho-emotional risk factors of NCDs\n2. Laboratory tests (analysis of glucose and cholesterol in the capillary blood, detection of microalbuminuria), diagnostic tests (electrocardiography, and carotid artery ultrasound)\n3. Evaluation of the results of questionnaires and surveys. Recommendations for lifestyle modification and follow-up in a local healthcare department', 'detailedDescription': "Currently the emphasis in preventive medicine is also on health of the working population, which is a key state policy in the Russian Federation. Health of working citizens is an important factor in the development and safety of the production sector, but it is also the key to health and well-being of all other groups - children and older generations - that is, in fact, the fundamental factor for social development. Therefore, the integration of health-saving technologies into all areas of working life, including production and work activities, is particularly important. In today's world, it is very important that everyone actively participate in the preservation the health of the individual and its high awareness. Awareness of risk factors for chronic non-communicable diseases and measures prevention throughout life is an important part of a healthy society. Monitoring the health of working citizens allows to predict the problem and take the necessary measures in a timely manner.\n\nIn the Russian Federation, medical screening is a complex system, including medical examination by physicians of several specialties and application of the necessary methods of examination to identify chronic non-communicable diseases and their risk factors at an early stage that are the main cause of disability and premature mortality in the country's population, and also to form health status groups and provide recommendations for patients. The examination is carried out once every three years and includes a set of methods of advanced examination to identify early on the most likely chronic non-communicable disease for a given age and gender. Regular checkups are the most important mass and highly effective medical technology of health savings.\n\nThe work of carrying out regular preventive examinations and check-ups is carried out by primary health care. Often the quality of such work is limited by manpower shortages, technological and logistical barriers. In modern conditions, these obstacles can be overcome by using mobile systems that include modern digital diagnostic technologies, Allow for more in-depth investigation and identification of risk factors not covered by the standard examination protocol. This will increase the coverage and detection of risk factors, which is an important component of the health saving of the working population"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study is planned to include all working citizens who meet the inclusion criteria and have come for preventive examination. In total, at least 2,000 people are planned to be included in the study. All participants will be given informed consent to participate in the clinical trial', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employees of the company\n* persons without NCDs diagnosis and not receiving permanent medication\n* residents of the region of the Russian Federation where a factory with permanent or temporary registration is located\n\nExclusion Criteria:\n\n* refusal to sign informed consent\n* any NCDs requiring constant medication\n* active cancer\n* pulmonary embolism\n* valve defects of the heart (except secondary mitral regurgitation)'}, 'identificationModule': {'nctId': 'NCT06812767', 'acronym': 'FORTUNE', 'briefTitle': 'Risk Factors at Chronic Non-communicable Diseases in People of Working Age', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Therapy and Preventive Medicine'}, 'officialTitle': 'Risk Factors at Chronic Non-communicable Diseases in People of Working Age', 'orgStudyIdInfo': {'id': '05-05/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons without NCDs', 'description': 'Persons without known NCDs and not using any medication on a permanent basis', 'interventionNames': ['Diagnostic Test: electrocardiography', 'Diagnostic Test: analysis for glucose and cholesterol in the capillary blood', 'Diagnostic Test: detection of microalbumuria', 'Diagnostic Test: heart ultrasound examination', 'Diagnostic Test: carotid artery ultrasound examination']}], 'interventions': [{'name': 'electrocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': '12 standard leads', 'armGroupLabels': ['Persons without NCDs']}, {'name': 'analysis for glucose and cholesterol in the capillary blood', 'type': 'DIAGNOSTIC_TEST', 'description': 'express test', 'armGroupLabels': ['Persons without NCDs']}, {'name': 'detection of microalbumuria', 'type': 'DIAGNOSTIC_TEST', 'description': 'express test', 'armGroupLabels': ['Persons without NCDs']}, {'name': 'heart ultrasound examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound examination with Lumify Handheld S4-1 Phased Array Ultrasound (Philips)', 'armGroupLabels': ['Persons without NCDs']}, {'name': 'carotid artery ultrasound examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound examination with Lumify Handheld L12-4 Linear Array Ultrasound (Philips)', 'armGroupLabels': ['Persons without NCDs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'National Medical Research Center for Therapy and Preventive Medicine', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Olga Dzhioeva, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Medical Research Center for Therapy and Preventive Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center for Therapy and Preventive Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}