NCT04306822

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22,906

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

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

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 10, 2020

Last Update Submit

March 13, 2020

Conditions

Keywords

epidemiologyrisk factoradultnon-communicable diseasescardio-vascular diseasesdietary habitsarterial hypertensionsmokingphysical activityhypercholesterinemia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability 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%).

You may qualify if:

  • randomly selected males and females aged 25-64 years from 13 regions of Russian Federation

You may not qualify if:

  • males and females younger than 24 years and older than 64 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Noncommunicable DiseasesCardiovascular DiseasesFeeding BehaviorHypertensionSmokingMotor Activity

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 13, 2020

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03