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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

3,125

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.8 years study duration

Study Start

First participant enrolled

April 1, 2011

Completed

6.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed

Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

9.8 years

First QC Date

September 22, 2017

Last Update Submit

January 27, 2020

Conditions

Cardiovascular Risk Factor Cardiovascular Diseases

Keywords

HypertensionDiabetesDyslipidemiaSmokingCardiovascularToledo

Outcome Measures

Primary Outcomes (3)

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
Prevalence of cardiovascular risk factors
To assess the prevalence of cardiovascular risk factors
December 2020
Prevalence of cardiovascular disease
To assess the prevalence of cardiovascular disease
December 2020

Study Arms (1)

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

ObservationalOTHER

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

Cohort of the study

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Sites (1)

Avenida de Irlanda, 12, 2º A

Toledo, 45005, Spain

RECRUITING

Related Publications (5)

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.
PMID: 28869129RESULT
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.
PMID: 28566229RESULT
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.
PMID: 24646328RESULT
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.
PMID: 24034757RESULT
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.
PMID: 28284813RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Total blood and serum samples will be frozen (-85ºC) for future genetic studies.

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionDiabetes MellitusDyslipidemiasSmoking

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersBehavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Gustavo C Rodriguez-Roca, MD, PhD

CONTACT

608293478 gcrodriguezroca@gmail.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 5 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director & principal Investigator, Clinical Professor

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 27, 2017

Study Start

April 1, 2011

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations

ES(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Cohort of the study

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations