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Clinical Trials/NCT03294369
NCT03294369UnknownNot Applicable

RIesgo CARdiovascular y Eventos Cardiovasculares en la población General Del área Sanitaria de TOledo

Castilla-La Mancha Health Service1 site in 1 country3,125 target enrollmentStarted: April 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
3,125
Locations
1
Primary Endpoint
Assess cardiovascular risk of the study population

Study Overview

Brief Summary

This epidemiological and observational study is aimed to assess cardiovascular risk (CVR) by investigating the prevalence of CVR factors (CVRF), target organ damage (TOD) and cardiovascular disease (CVD) in general population of the sanitary area of Toledo.

Detailed Description

Epidemiological and observational study that is analyzing a sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender.

Clinical history, physical examination and complementary tests are being performed.

Total blood and serum samples are being frozen (-85ºC) for future genetic studies. The biobank is currently being registered at the "Virgen de la Salud" hospital of Toledo.

CVR is assessed by SCORE scale calibrated for Spanish population and the Framingham Heart Study scale.

Patients will be periodically visited, with a minimum follow-up of 5 years. Standard statistical analysis will be performed.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender

Exclusion Criteria

  • Individulas aged under 18 years.
  • Subjects who do not sign the informed consent.
  • Subjects that due to different conditions (physical, mental or social) is expected that do not complete the expected follow-up.

Outcomes

Primary Outcomes

Assess cardiovascular risk of the study population

Time Frame: December 2020

Cardiovascular risk will be determined according to SCORE scale calibrated for Spanish population and the Framingham Heart Study scale.

Prevalence of cardiovascular risk factors

Time Frame: December 2020

To assess the prevalence of cardiovascular risk factors

Prevalence of cardiovascular disease

Time Frame: December 2020

To assess the prevalence of cardiovascular disease

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Castilla-La Mancha Health Service
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gustavo Rodriguez Roca

Director & principal Investigator, Clinical Professor

Castilla-La Mancha Health Service

Study Sites (1)

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