Cardiovascular Risk in Toledo Population

• Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases
• Interventions: Other: Observational

• Registration Number: NCT03294369
• Lead Sponsor: Castilla-La Mancha Health Service

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 Timeline

• Study Start: 2011-04-01
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of the study	Observational	A sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender.

Primary Outcome Measures

Name	Time	Method
Assess cardiovascular risk of the study population	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	December 2020	To assess the prevalence of cardiovascular risk factors
Prevalence of cardiovascular disease	December 2020	To assess the prevalence of cardiovascular disease

Trial Locations

Locations (1)

Avenida de Irlanda, 12, 2º A; 🇪🇸 Toledo, Spain