Cardiovascular Risk FactorRICARTONCT03294369
Cardiovascular Risk in Toledo Population
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by Castilla-La Mancha Health Service at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases
- What is being tested?
- Observational
- How many people
- 3,125 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2011to 31 Dec 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender
Who may be able to join
- Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Avenida de Irlanda, 12, 2º A
Toledo, 45005
Gustavo C Rodriguez-Roca, MD, PhD, 608293478, gcrodriguezroca@gmail.com
Francisco J Alonso-Moreno, MD, PhD
About this study
Official title: 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.
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.
- Being tested
- Observational
- Keywords
- Hypertension, Diabetes, Dyslipidemia, Smoking, Cardiovascular, Toledo
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Dyslipidemias, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2020
Prevalence of cardiovascular risk factors
To assess the prevalence of cardiovascular risk factors
Measured: December 2020
Prevalence of cardiovascular disease
To assess the prevalence of cardiovascular disease
Measured: December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Apr 2011
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,125 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Collaborators
- Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha), SEMERGEN (Spanish Society of Primary Care Physicians)
- Responsible party
- Principal investigator, Gustavo Rodriguez Roca, Castilla-La Mancha Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294369
- Sponsor's protocol ID
- RICARTO
- Acronym
- RICARTO
- Status last verified
- Jan 2020
- First submitted
- 22 Sep 2017
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 28869129Rodriguez-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 28566229Rodriguez-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 24646328Rodriguez-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 24034757Rodriguez 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIesgo CARdiovascular y Eventos Cardiovasculares en la población General Del área Sanitaria de TOledo
- ClinicalTrials.gov ID
- NCT03294369
- Acronym / sponsor ID
- RICARTO / RICARTO
- Keywords
- Hypertension, Diabetes, Dyslipidemia, Smoking, Cardiovascular, Toledo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,125 participants (estimated)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Collaborators
- Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha), SEMERGEN (Spanish Society of Primary Care Physicians)
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of the study | – | Other: ObservationalA sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender
Key inclusion criteria (1 listed)
- Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study. | Other | Cohort of the study |
Primary outcome
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.
Prevalence of cardiovascular risk factors
Time frame: December 2020
To assess the prevalence of cardiovascular risk factors
Prevalence of cardiovascular disease
Time frame: December 2020
To assess the prevalence of cardiovascular disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Results publication: PubMed 28869129Rodriguez-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.
- Results publication: PubMed 28566229Rodriguez-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.
- Results publication: PubMed 24646328Rodriguez-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.
- Results publication: PubMed 24034757Rodriguez-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.
- Results publication: PubMed 28284813Rodriguez 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by Castilla-La Mancha Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo C Rodriguez-Roca, MD, PhD (608293478, gcrodriguezroca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess cardiovascular risk of the study population (time frame: December 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294369, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.