CClinicalTrials.gg
Sign In
Status unknownNCT03294369RICARTOUpdated Jan 29, 2020

Cardiovascular Risk in Toledo Population

An observational study in Cardiovascular Risk Factor and Cardiovascular Diseases, sponsored by Castilla-La Mancha Health Service. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-29.

Sponsored by Castilla-La Mancha Health Service · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,125
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Risk Factor
  • Cardiovascular Diseases

Keywords

  • Hypertension
  • Diabetes
  • Dyslipidemia
  • Smoking
  • Cardiovascular
  • Toledo
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,125 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherObservational

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: December 2020

  2. Prevalence of cardiovascular risk factors

    To assess the prevalence of cardiovascular risk factors

    Time frame: December 2020

  3. Prevalence of cardiovascular disease

    To assess the prevalence of cardiovascular disease

    Time frame: December 2020

06

Study locations

1 of 1 sites recruiting
  • Avenida de Irlanda, 12, 2º A
    Toledo, 45005, Spain
    • Gustavo C Rodriguez-Roca, MD, PhD · Contact · gcrodriguezroca@gmail.com · 608293478
    • 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 · Sub investigator
    Recruiting
07

References and documents

Publications

  • Rodriguez-Roca GC, Segura-Fragoso A, Villarin-Castro A, Alonso-Moreno FJ, Rodriguez-Padial L, Rodriguez-Garcia ML, Fernandez-Conde JA, Rojas-Martelo GA, Menchen-Herreros A, Escobar-Cervantes C, Fernandez-Martin J, Artigao-Rodenas LM, Carbayo-Herencia JA, Hernandez-Moreno J; en representacion del grupo de trabajo RICARTO. [Characteristics and cardiovascular events in a general population included in the RICARTO (RIesgo CARdiovascular TOledo) study: Data from the first 1,500 individuals included in the study]. Semergen. 2018 Apr;44(3):180-191. doi: 10.1016/j.semerg.2017.07.002. Epub 2017 Aug 30. Spanish. PubMed 28869129 ↗
  • Rodriguez-Roca GC, Rodriguez-Padial L, Alonso-Moreno FJ, Segura-Fragoso A, Villarin-Castro A, Rodriguez-Garcia ML, Menchen-Herreros A, Rojas-Martelo GA, Fernandez-Conde JA, Artigao-Rodenas LM, Carbayo-Herencia JA, Escobar-Cervantes C, Hernandez-Moreno J, Fernandez-Martin J; en representacion del grupo de trabajo RICARTO. [Cardiovascular risk and cardiovascular events in the general population of the sanitary area of Toledo. RICARTO Study]. Semergen. 2018 Mar;44(2):107-113. doi: 10.1016/j.semerg.2017.04.007. Epub 2017 May 27. Spanish. PubMed 28566229 ↗
  • Rodriguez-Roca GC, Villarin-Castro A, Carrasco-Flores J, Artigao-Rodenas LM, Carbayo-Herencia JA, Escobar-Cervantes C, Alonso-Moreno FJ, Segura-Fragoso A, Gomez-Serranillos M, Hernandez-Moreno J; RICARTO (Riesgo Cardiovascular Y Eventos Cardiovasculares En La Poblacion General del Area Sanitaria De Toledo) Project Working Group. Concordance between automated oscillometric measurement of ankle-brachial index and traditional measurement by eco-Doppler in patients without peripheral artery disease. Blood Press. 2014 Oct;23(5):270-5. doi: 10.3109/08037051.2013.876796. Epub 2014 Mar 19. PubMed 24646328 ↗
  • Rodriguez-Roca GC, Rodriguez-Padial L, Alonso-Moreno FJ, Romero-Gutierrez A, Akerstrom F, Segura-Fragoso A, Villarin-Castro A, Hernandez-Moreno J, Menchen-Herreros A, Gomez-Serranillos M, Artigao-Rodenas LM; grupo de trabajo del estudio RICARTO. [Lipid profile in patients admitted with acute coronary syndrome in Spain: data from Toledo health care area between 2005 and 2008]. Semergen. 2013 Sep;39(6):298-303. doi: 10.1016/j.semerg.2012.11.001. Epub 2012 Dec 20. Spanish. PubMed 24034757 ↗
  • Rodriguez Padial L, Segura Fragoso A, Alonso Moreno FJ, Arias MA, Villarin Castro A, Rodriguez 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;149(2):72-74. doi: 10.1016/j.medcli.2017.01.013. Epub 2017 Mar 9. English, Spanish. PubMed 28284813 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03294369
Lead 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)
Responsible party
Gustavo Rodriguez Roca (Director & principal Investigator, Clinical Professor, Castilla-La Mancha Health Service) — Principal investigator
First posted
Sep 27, 2017
Start date
Apr 1, 2011
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jan 29, 2020

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Castilla-La Mancha Health Service

Start the discussion