Clinical trial NCT04306822: Epidemiology of Cardiovascular Diseases and Their Risk Factors in Regions of Russian Federation
Official title: Epidemiology of Cardiovascular Diseases and Their Risk Factors in Regions of Russian Federation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factor, Cardiovascular
Non-communicable Diseases
Cardiovascular Diseases
Keywords: epidemiology
risk factor
adult
non-communicable diseases
cardio-vascular diseases
dietary habits
arterial hypertension
smoking
physical activity
hypercholesterinemia
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
First posted: 2020-03-13
Enrollment: 22906
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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%).

Brief 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 "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.

Eligibility criteria: Inclusion Criteria:

* randomly selected males and females aged 25-64 years from 13 regions of Russian Federation

Exclusion Criteria:

* males and females younger than 24 years and older than 64 years

Primary outcomes:
measure: The number of fatal and non-fatal events
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
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Study officials:
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