Chronic Non-communicable DiseaseFORTUNENCT06812767
Risk Factors at Chronic Non-communicable Diseases in People of Working Age
An observational study of Chronic Non-communicable Disease, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Non-communicable Disease
- What is being tested?
- electrocardiography, analysis for glucose and cholesterol in the capillary blood and detection of microalbumuria
- How many people
- 2,000 participants
- Where
- 1 siteRussia
- Study dates
- Apr 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- employees of the company
- persons without NCDs diagnosis and not receiving permanent medication
- residents of the region of the Russian Federation where a factory with permanent or temporary registration is located
Who cannot join
- refusal to sign informed consent
- any NCDs requiring constant medication
- active cancer
- pulmonary embolism
- valve defects of the heart (except secondary mitral regurgitation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
National Medical Research Center for Therapy and Preventive Medicine
Moscow
About this study
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.
Research stages:
- Questionnaire to identify socio-demographic, behavioral, hereditary, psycho-emotional risk factors of NCDs
- Laboratory tests (analysis of glucose and cholesterol in the capillary blood, detection of microalbuminuria), diagnostic tests (electrocardiography, and carotid artery ultrasound)
- Evaluation of the results of questionnaires and surveys. Recommendations for lifestyle modification and follow-up in a local healthcare department
Read the detailed description
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.
In 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.
The 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
- Conditions
- Chronic Non-communicable Disease
- Being tested
- electrocardiography, analysis for glucose and cholesterol in the capillary blood, detection of microalbumuria, heart ultrasound examination, carotid artery ultrasound examination
- 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
- Medical subject headings
- Noncommunicable Diseases, Hypertension, Coronary Disease, Cerebrovascular Disorders, Neoplasms, Pulmonary Disease, Chronic Obstructive, Asthma, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiographyDiagnostic test
12 standard leads
analysis for glucose and cholesterol in the capillary bloodDiagnostic test
express test
detection of microalbumuriaDiagnostic test
express test
heart ultrasound examinationDiagnostic test
Ultrasound examination with Lumify Handheld S4-1 Phased Array Ultrasound (Philips)
carotid artery ultrasound examinationDiagnostic test
Ultrasound examination with Lumify Handheld L12-4 Linear Array Ultrasound (Philips)
| Study group | Role | What they receive |
|---|---|---|
| Persons without NCDs | Persons without known NCDs and not using any medication on a permanent basis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of NCDs risk factors
risk factors of NCDs based on survey results and diagnostic tests
Measured: on enrollment
prevalence of NCDs
diagnosed NCDs based on survey results, and diagnostic tests
Measured: on enrollment
Secondary outcomes (1)
Hospitalization
Urgent or emergent hospitalization during the visit if indicated
Measured: on enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-communicable DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olga Dzhioeva, MD, PhD, Study director, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812767
- Sponsor's protocol ID
- 05-05/24
- Acronym
- FORTUNE
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors at Chronic Non-communicable Diseases in People of Working Age
- ClinicalTrials.gov ID
- NCT06812767
- Acronym / sponsor ID
- FORTUNE / 05-05/24
- Conditions
- Chronic Non-communicable Disease
- Keywords
- arterial hypertension, coronary heart disease, cerebrovascular disease, malignant tumors, chronic obstructive pulmonary disease, asthma, diabetes mellitus, environment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Research stages:
- Questionnaire to identify socio-demographic, behavioral, hereditary, psycho-emotional risk factors of NCDs
- Laboratory tests (analysis of glucose and cholesterol in the capillary blood, detection of microalbuminuria), diagnostic tests (electrocardiography, and carotid artery ultrasound)
- Evaluation of the results of questionnaires and surveys. Recommendations for lifestyle modification and follow-up in a local healthcare department
Detailed description
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.
In 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.
The 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons without NCDs | – | 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 examinationPersons without known NCDs and not using any medication on a permanent basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- employees of the company
- persons without NCDs diagnosis and not receiving permanent medication
- residents of the region of the Russian Federation where a factory with permanent or temporary registration is located
Key exclusion criteria (5 listed)
- refusal to sign informed consent
- any NCDs requiring constant medication
- active cancer
- pulmonary embolism
- valve defects of the heart (except secondary mitral regurgitation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocardiography12 standard leads | Diagnostic test | Persons without NCDs |
| analysis for glucose and cholesterol in the capillary bloodexpress test | Diagnostic test | Persons without NCDs |
| detection of microalbumuriaexpress test | Diagnostic test | Persons without NCDs |
| heart ultrasound examinationUltrasound examination with Lumify Handheld S4-1 Phased Array Ultrasound (Philips) | Diagnostic test | Persons without NCDs |
| carotid artery ultrasound examinationUltrasound examination with Lumify Handheld L12-4 Linear Array Ultrasound (Philips) | Diagnostic test | Persons without NCDs |
Primary outcome
prevalence of NCDs risk factors
Time frame: on enrollment
risk factors of NCDs based on survey results and diagnostic tests
prevalence of NCDs
Time frame: on enrollment
diagnosed NCDs based on survey results, and diagnostic tests
1 secondary outcome
Hospitalization
Time frame: on enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Dzhioeva, MD, PhD study director
National Medical Research Center for Therapy and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Non-communicable Disease, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of NCDs risk factors (time frame: on enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.