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Cardiovascular Risk in Toledo Population (RICARTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294369
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : January 29, 2020
Sponsor:
Collaborators:
Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha)
SEMERGEN (Spanish Society of Primary Care Physicians)
Information provided by (Responsible Party):
Gustavo Rodriguez Roca, 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.

Condition or disease Intervention/treatment
Cardiovascular Risk Factor Cardiovascular Diseases Other: Observational

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: RIesgo CARdiovascular y Eventos Cardiovasculares en la población General Del área Sanitaria de TOledo
Actual Study Start Date : April 1, 2011
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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.




Primary Outcome Measures :
  1. 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.

  2. Prevalence of cardiovascular risk factors [ Time Frame: December 2020 ]
    To assess the prevalence of cardiovascular risk factors

  3. Prevalence of cardiovascular disease [ Time Frame: December 2020 ]
    To assess the prevalence of cardiovascular disease


Biospecimen Retention:   Samples With DNA
Total blood and serum samples will be frozen (-85ºC) for future genetic studies.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294369


Contacts
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Contact: Gustavo C Rodriguez-Roca, MD, PhD 608293478 gcrodriguezroca@gmail.com

Locations
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Spain
Avenida de Irlanda, 12, 2º A Recruiting
Toledo, Spain, 45005
Contact: Gustavo C Rodriguez-Roca, MD, PhD    608293478    gcrodriguezroca@gmail.com   
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         
Sponsors and Collaborators
Castilla-La Mancha Health Service
Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha)
SEMERGEN (Spanish Society of Primary Care Physicians)
Additional Information:

Publications of Results:

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Responsible Party: Gustavo Rodriguez Roca, Director & principal Investigator, Clinical Professor, Castilla-La Mancha Health Service
ClinicalTrials.gov Identifier: NCT03294369    
Other Study ID Numbers: RICARTO
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gustavo Rodriguez Roca, Castilla-La Mancha Health Service:
Hypertension
Diabetes
Dyslipidemia
Smoking
Cardiovascular
Toledo
Additional relevant MeSH terms:
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Cardiovascular Diseases