Cardiovascular Epidemiology in Russian Federation (ESSE-RF)

August 1, 2016 updated by: Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

18000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Orenburg, Russian Federation
        • Recruiting
        • Orenburg Medical Academi
        • Contact:
          • Roman Libis, Prof
          • Phone Number: 79111555524
          • Email: libis@mail.ru
        • Principal Investigator:
          • Roman Libis, Prof
      • Samara, Russian Federation
        • Recruiting
        • Samara medical university
        • Contact:
        • Principal Investigator:
          • Dmitriy Duplyakov, prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Random sample population

Description

Inclusion Criteria:

- informed consent

Exclusion Criteria:

No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortality
Time Frame: 10 years
all cause motality registered by official statistics
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 10 years
10 years
Stroke
Time Frame: 10 years
ischemic and heamorragic stroke
10 years
Miocardial infarction
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Collaborators

Russian Cardiology Research and Production Center
National Research Center for Preventive Medicine

Investigators

  • Study Chair: Svetlana A Shalnova, Prof, State Sientific Center of Preventive Medicine
  • Principal Investigator: Alexandra O Konradi, Prof, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  • Principal Investigator: Eugene I Chazov, Prof, Russian Research and Production Complex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlmazovFCHBE-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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