Cardiovascular Risk in Toledo Population (RICARTO)

January 27, 2020 updated by: Gustavo Rodriguez Roca, Castilla-La Mancha Health Service

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45005
        • Recruiting
        • Avenida de Irlanda, 12, 2º A
        • Contact:
        • Sub-Investigator:
          • Francisco J Alonso-Moreno, MD, PhD
        • Sub-Investigator:
          • Alejandro Villarin-Castro, MD
        • Sub-Investigator:
          • Antonio Segura-Fragoso, MD, PhD
        • Sub-Investigator:
          • Luis Rodriguez-Padial, MD, PhD
        • Sub-Investigator:
          • Juan Fernandez-Martin, MD, PhD
        • Sub-Investigator:
          • Carlos Escobar-Cervantes, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort of the study
A sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender.
Other: Observational
This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
December 2020
Prevalence of cardiovascular risk factors
Time Frame: December 2020
To assess the prevalence of cardiovascular risk factors
December 2020
Prevalence of cardiovascular disease
Time Frame: December 2020
To assess the prevalence of cardiovascular disease
December 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Collaborators

Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha)
SEMERGEN (Spanish Society of Primary Care Physicians)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RICARTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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