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NCT02449460 Clinical Trial

Cardiovascular Epidemiology in Russian Federation

Hypertension Clinical Trial

— ESSE-RF  

Official title:
Multicenter Observational Study of Epidemiology of Cardiovascular Diseases and Risk Factors in Different Regions of Russian Federation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02449460
Other study ID # AlmazovFCHBE-4
Secondary ID
Status Recruiting
Phase N/A
First received May 18, 2015
Last updated August 1, 2016
Start date July 2012
Est. completion date December 2022

Study information
Verified date July 2016
Source Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Contact Eugene V Shlyakhto, Prof
Phone 78127023700
Email e.shlyakhto@almazovcentre.ru
Is FDA regulated No
Health authority Ministry of Health: Russian Federation
Study type Observational

Clinical Trial Summary

The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.

Description:

Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation

Recruitment information / eligibility
Status Recruiting
Enrollment 18000
Est. completion date December 2022
Est. primary completion date March 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- informed consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Orenburg Medical Academi Orenburg
Russian Federation Samara Medical University Samara

Sponsors (3)
Lead Sponsor Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health National Research Center for Preventive Medicine, Russian Cardiology Research and Production Center

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary all cause mortality all cause motality registered by official statistics 10 years No
Secondary Stroke ischemic and heamorragic stroke 10 years No
Secondary Miocardial infarction 10 years No
Secondary Cardiovascular mortality 10 years No
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