Epidemiology of Cardiovascular Diseases and Their Risk Factors in Regions of Russian Federation (ECVD-RF)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Risk Factor, Cardiovascular; Non-communicable Diseases

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 Type: Observational
• Enrollment (Actual): 22906

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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%).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 years

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• 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 record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; adult; smoking; epidemiology; arterial hypertension; risk factor; non-communicable diseases; dietary habits; cardio-vascular diseases; hypercholesterinemia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Cardiovascular Diseases; Noncommunicable Diseases
• Other Study ID Numbers: 01201178178