Cardiovascular Diseases Clinical Trial
— ECVD-RFOfficial title:
Epidemiology of Cardiovascular Diseases and Their Risk Factors in Regions of Russian Federation
NCT number | NCT04306822 |
Other study ID # | 01201178178 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | January 2020 |
Verified date | March 2020 |
Source | National Research Center for Preventive Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 22906 |
Est. completion date | January 2020 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | |
Gender | All |
Age group | 25 Years to 64 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Research Center for Preventive Medicine | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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