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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03294369
Other study ID # RICARTO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2011
Est. completion date December 31, 2020

Study information

Verified date January 2020
Source Castilla-La Mancha Health Service
Contact Gustavo C Rodriguez-Roca, MD, PhD
Phone 608293478
Email gcrodriguezroca@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 (-85ÂșC) 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3125
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Observational
This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.

Locations

Country Name City State
Spain Avenida de Irlanda, 12, 2º A Toledo

Sponsors (3)

Lead Sponsor Collaborator
Castilla-La Mancha Health Service Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha), SEMERGEN (Spanish Society of Primary Care Physicians)

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Rodríguez Padial L, Segura Fragoso A, Alonso Moreno FJ, Arias MA, Villarín Castro A, Rodríguez Roca GC. Blood pressure differences between one automatic measurement and the mean value of 3 automatic measurements. SPRINT trial. Med Clin (Barc). 2017 Jul 21 — View Citation

Rodríguez-Roca GC, Rodríguez-Padial L, Alonso-Moreno FJ, Romero-Gutiérrez A, Akerström F, Segura-Fragoso A, Villarín-Castro A, Hernández-Moreno J, Menchén-Herreros A, Gómez-Serranillos M, Artigao-Rodenas LM; grupo de trabajo del estudio RICARTO. [Lipid pr — View Citation

Rodríguez-Roca GC, Rodríguez-Padial L, Alonso-Moreno FJ, Segura-Fragoso A, Villarín-Castro A, Rodríguez-García ML, Menchén-Herreros A, Rojas-Martelo GA, Fernández-Conde JA, Artigao-Rodenas LM, Carbayo-Herencia JA, Escobar-Cervantes C, Hernández-Moreno J, — View Citation

Rodríguez-Roca GC, Segura-Fragoso A, Villarín-Castro A, Alonso-Moreno FJ, Rodríguez-Padial L, Rodríguez-García ML, Fernández-Conde JA, Rojas-Martelo GA, Menchén-Herreros A, Escobar-Cervantes C, Fernández-Martín J, Artigao-Rodenas LM, Carbayo-Herencia JA, — View Citation

Rodriguez-Roca GC, Villarín-Castro A, Carrasco-Flores J, Artigao-Rodenas LM, Carbayo-Herencia JA, Escobar-Cervantes C, Alonso-Moreno FJ, Segura-Fragoso A, Gómez-Serranillos M, Hernández-Moreno J; RICARTO (Riesgo Cardiovascular Y Eventos Cardiovasculares E — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assess cardiovascular risk of the study population Cardiovascular risk will be determined according to SCORE scale calibrated for Spanish population and the Framingham Heart Study scale. December 2020
Primary Prevalence of cardiovascular risk factors To assess the prevalence of cardiovascular risk factors December 2020
Primary Prevalence of cardiovascular disease To assess the prevalence of cardiovascular disease December 2020
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