Cardiovascular Epidemiology in Russian Federation | NCT02449460

Studies
Cardiovascular Epidemiology in Russian Federation

NCT02449460

Sponsor

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

Status

Unknown status

Last Update Posted

Aug 2, 2016Estimated

Enrollment

18,000Estimated

Phase

Not provided

Conditions

Hypertension
Coronary Artery Disease
Diabetes
Heart Failure
Smoking
Lifestyle

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Mar 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

May 18, 2015

First Submission Date that Met QC Criteria

May 18, 2015

First Posted Date

May 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2016

Last Update Posted Date

Aug 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Conrady Alexandra, professor, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
National Research Center for Preventive Medicine	OTHER_GOV
Russian Cardiology Research and Production Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- informed consent

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Random sample population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eugene V Shlyakhto, Prof	Contact	78127023700		e.shlyakhto@almazovcentre.ru
Sergey A Boytsov, Prof	Contact	74953641159		profboytsov@mail.ru

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orenburg Medical Academi	Recruiting	Orenburg			Russia

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003324	Coronary Artery Disease
D003920	Diabetes Mellitus
D006333	Heart Failure
D012907	Smoking

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia

Browse Leaves

Not provided

Browse Branches

Not provided