NCT02449460

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

8.7 years

First QC Date

May 18, 2015

Last Update Submit

August 1, 2016

Conditions

HypertensionCoronary Artery DiseaseDiabetesHeart FailureSmokingLifestyle

Keywords

hypertensionepidemiologyglucosebody mass indexlipidssmokingcoronary artery diseasearterial stiffnesscarotid ultrasound

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    all cause motality registered by official statistics

    10 years

Secondary Outcomes (3)

  • Stroke

    10 years

  • Miocardial infarction

    10 years

  • Cardiovascular mortality

    10 years

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Random sample population

You may qualify if:

  • \- informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orenburg Medical Academi

Orenburg, Russia

RECRUITING

Samara Medical University

Samara, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood serum plasma urine

MeSH Terms

Conditions

HypertensionCoronary Artery DiseaseDiabetes MellitusHeart FailureSmoking

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Svetlana A Shalnova, Prof

    State Sientific Center of Preventive Medicine

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene V Shlyakhto, Prof

CONTACT

78127023700e.shlyakhto@almazovcentre.ru

Sergey A Boytsov, Prof

CONTACT

74953641159profboytsov@mail.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 20, 2015

Study Start

July 1, 2012

Primary Completion

March 1, 2021

Study Completion

December 1, 2022

Last Updated

August 2, 2016

Record last verified: 2016-07

Locations

RU(2)