Risk Factor, CardiovascularECVD-RFNCT04306822
Epidemiology of Cardiovascular Diseases and Their Risk Factors in Regions of Russian Federation
An observational study of Risk Factor, Cardiovascular and Non-communicable Diseases, run by National Research Center for Preventive Medicine.
Trial summary
The study carried out in 2012-2014 years. The aim was to evaluate the prevalence of CVD and their RF in different regions of the Russian Federation and to develop epidemiological models of the CVD risk profile for the population based on traditional factors, as well as to assess the contribution of traditional and… Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Risk Factor, Cardiovascular, Non-communicable Diseases, Cardiovascular Diseases
- How many people
- 22,906 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 64 years
- All sexes
- Adult
Study population: The study participants were randomly selected from 13 regions of Russian Federation between 2012-2014. The final sample included 22,906 individuals (8353 males, 13553 females) who completed an interview and medical tests (response rate 80%).
Who may be able to join
- randomly selected males and females aged 25-64 years from 13 regions of Russian Federation
Who cannot join
- males and females younger than 24 years and older than 64 years
About this study
The study carried out in 2012-2014 years. The aim was to evaluate the prevalence of CVD and their RF in different regions of the Russian Federation and to develop epidemiological models of the CVD risk profile for the population based on traditional factors, as well as to assess the contribution of traditional and "new" cardiovascular risk factors to the mortality rate of the country's population based on domestic data. Thirteen regions were included. We examined 22,906 males and females, aged 25-64 years. The examination consist of anthropometry; the measurement of BP, resting heart rate, and a 12-lead standard electrocardiography (ECG) in a supine position. The personal interview information was collected using a structured questionnaire, and included socio-demographic and socio-economic measures; health parameters; medical history; stress, and depression. Continued monitoring of mortality, the latest mortality update includes deaths through 2019.
Read the detailed description
The representative (systematic stratified multistage) random sample was generated according to the territorial principle (Kish method) in 13 regions of the Russian Federation. The study sample included 22,906 participants (8353 males and 13553 females) 25-64 years old, with a response rate - 80%, examined in 2012-2014. The following regions were included: Volgograd, Voronezh, Vologda, Ivanovo, Kemerovo, Orenburg, Samara, Tomsk, Tyumen regions, St. Petersburg, Krasnoyarsk, Primorsky Territory and the Republic of North Ossetia-Alania. All of the subjects were examined using a standard questionnaire consisting of 12 modules and containing information on age and gender composition, educational status, professional affiliation, level of well-being of survey participants, the presence of behavioral risk factors: smoking, excessive alcohol consumption, low physical activity, poor nutrition, as well as anxiety and depressive disorders. In addition, the questionnaire included anamnestic data on chronic diseases and drug therapy. Quality of life was assessed using the EUROQOL international questionnaire - EQ-5D All subjects were measured blood pressure (BP) and heart rate twice according to the standard procedure. Anthropometric procedures included measuring weight (kg), height (m), waist circumference (cm), calculating body mass index (BMI; kg / m2). The lipid profile was determined for all patients, including levels of HDL and HDL cholesterol, triglycerides, as well as glucose, creatinine and uric acid. The levels of these parameters in blood serum were determined by Abbot Architect c8000 biochemical analyzer (USA). The Additional Screening program, included sphygmomanometry, duplex scanning of carotid arteries, and evaluation of the parameters characterizing the functioning of metabolic systems (apo B and apo AI, as well as LP (a), C-reactive protein (hsCRP), NT-proBNP - the N-terminal propeptide of cerebral natriuretic hormone B-type, dash Nootropic hormone (TSH), insulin, D-dimer) in addition to the main survey was conducted in the 5 regions.Continued monitoring of mortality. Deaths were verified in residential registers and from telephone calls. The latest mortality update includes deaths through 2019.
- Keywords
- epidemiology, risk factor, adult, non-communicable diseases, cardio-vascular diseases, dietary habits, arterial hypertension, smoking, physical activity, hypercholesterinemia
- Medical subject headings
- Noncommunicable Diseases, Cardiovascular Diseases, Feeding Behavior, Hypertension, Smoking, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of fatal and non-fatal events
cardiovascular death, noncardiovascular death, all-cause death, the triple composite of cardiovascular death, non-fatal MI or non-fatal stroke, fatal MI, fatal stroke, non-fatal MI, non-fatal stroke, hospitalization for HF, coronary angiography, PCI, and CABG
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factor, CardiovascularStudies 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
- Prospective
- Enrolment
- 22,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306822
- Sponsor's protocol ID
- 01201178178
- Acronym
- ECVD-RF
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Cardiovascular Diseases and Their Risk Factors in Regions of Russian Federation
- ClinicalTrials.gov ID
- NCT04306822
- Acronym / sponsor ID
- ECVD-RF / 01201178178
- Keywords
- epidemiology, risk factor, adult, non-communicable diseases, cardio-vascular diseases, dietary habits, arterial hypertension, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,906 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 13 Mar 2020 (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.
The study carried out in 2012-2014 years. The aim was to evaluate the prevalence of CVD and their RF in different regions of the Russian Federation and to develop epidemiological models of the CVD risk profile for the population based on traditional factors, as well as to assess the contribution of traditional and "new" cardiovascular risk factors to the mortality rate of the country's population based on domestic data. Thirteen regions were included. We examined 22,906 males and females, aged 25-64 years. The examination consist of anthropometry; the measurement of BP, resting heart rate, and a 12-lead standard electrocardiography (ECG) in a supine position. The personal interview information was collected using a structured questionnaire, and included socio-demographic and socio-economic measures; health parameters; medical history; stress, and depression. Continued monitoring of mortality, the latest mortality update includes deaths through 2019.
Detailed description
The representative (systematic stratified multistage) random sample was generated according to the territorial principle (Kish method) in 13 regions of the Russian Federation. The study sample included 22,906 participants (8353 males and 13553 females) 25-64 years old, with a response rate - 80%, examined in 2012-2014. The following regions were included: Volgograd, Voronezh, Vologda, Ivanovo, Kemerovo, Orenburg, Samara, Tomsk, Tyumen regions, St. Petersburg, Krasnoyarsk, Primorsky Territory and the Republic of North Ossetia-Alania. All of the subjects were examined using a standard questionnaire consisting of 12 modules and containing information on age and gender composition, educational status, professional affiliation, level of well-being of survey participants, the presence of behavioral risk factors: smoking, excessive alcohol consumption, low physical activity, poor nutrition, as well as anxiety and depressive disorders. In addition, the questionnaire included anamnestic data on chronic diseases and drug therapy. Quality of life was assessed using the EUROQOL international questionnaire - EQ-5D All subjects were measured blood pressure (BP) and heart rate twice according to the standard procedure. Anthropometric procedures included measuring weight (kg), height (m), waist circumference (cm), calculating body mass index (BMI; kg / m2). The lipid profile was determined for all patients, including levels of HDL and HDL cholesterol, triglycerides, as well as glucose, creatinine and uric acid. The levels of these parameters in blood serum were determined by Abbot Architect c8000 biochemical analyzer (USA). The Additional Screening program, included sphygmomanometry, duplex scanning of carotid arteries, and evaluation of the parameters characterizing the functioning of metabolic systems (apo B and apo AI, as well as LP (a), C-reactive protein (hsCRP), NT-proBNP - the N-terminal propeptide of cerebral natriuretic hormone B-type, dash Nootropic hormone (TSH), insulin, D-dimer) in addition to the main survey was conducted in the 5 regions.Continued monitoring of mortality. Deaths were verified in residential registers and from telephone calls. The latest mortality update includes deaths through 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study participants were randomly selected from 13 regions of Russian Federation between 2012-2014. The final sample included 22,906 individuals (8353 males, 13553 females) who completed an interview and medical tests (response rate 80%).
Key inclusion criteria (1 listed)
- randomly selected males and females aged 25-64 years from 13 regions of Russian Federation
Key exclusion criteria (1 listed)
- males and females younger than 24 years and older than 64 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of fatal and non-fatal events
Time frame: 6 years
cardiovascular death, noncardiovascular death, all-cause death, the triple composite of cardiovascular death, non-fatal MI or non-fatal stroke, fatal MI, fatal stroke, non-fatal MI, non-fatal stroke, hospitalization for HF, coronary angiography, PCI, and CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factor, Cardiovascular and Non-communicable Diseases, run by National Research Center for Preventive Medicine.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of fatal and non-fatal events (time frame: 6 years). 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 17 Mar 2020.