<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294369</url>
  </required_header>
  <id_info>
    <org_study_id>RICARTO</org_study_id>
    <nct_id>NCT03294369</nct_id>
  </id_info>
  <brief_title>Cardiovascular Risk in Toledo Population</brief_title>
  <acronym>RICARTO</acronym>
  <official_title>RIesgo CARdiovascular y Eventos Cardiovasculares en la población General Del área Sanitaria de TOledo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Castilla-La Mancha Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SEMERGEN (Spanish Society of Primary Care Physicians)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Castilla-La Mancha Health Service</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This epidemiological and observational study is aimed to assess cardiovascular risk (CVR) by&#xD;
      investigating the prevalence of CVR factors (CVRF), target organ damage (TOD) and&#xD;
      cardiovascular disease (CVD) in general population of the sanitary area of Toledo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiological and observational study that is analyzing a sample from the general&#xD;
      population aged 18 years or older, randomly selected from a database of sanitary cards&#xD;
      stratified by age and gender.&#xD;
&#xD;
      Clinical history, physical examination and complementary tests are being performed.&#xD;
&#xD;
      Total blood and serum samples are being frozen (-85ºC) for future genetic studies. The&#xD;
      biobank is currently being registered at the &quot;Virgen de la Salud&quot; hospital of Toledo.&#xD;
&#xD;
      CVR is assessed by SCORE scale calibrated for Spanish population and the Framingham Heart&#xD;
      Study scale.&#xD;
&#xD;
      Patients will be periodically visited, with a minimum follow-up of 5 years. Standard&#xD;
      statistical analysis will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2011</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Assess cardiovascular risk of the study population</measure>
    <time_frame>December 2020</time_frame>
    <description>Cardiovascular risk will be determined according to SCORE scale calibrated for Spanish population and the Framingham Heart Study scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of cardiovascular risk factors</measure>
    <time_frame>December 2020</time_frame>
    <description>To assess the prevalence of cardiovascular risk factors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of cardiovascular disease</measure>
    <time_frame>December 2020</time_frame>
    <description>To assess the prevalence of cardiovascular disease</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3125</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Cohort of the study</arm_group_label>
    <description>A sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.</description>
    <arm_group_label>Cohort of the study</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Total blood and serum samples will be frozen (-85ºC) for future genetic studies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects aged 18 years or older, randomly selected from a database of health cards&#xD;
        stratified by age and gender&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18 years or older, randomly selected from a database of health cards&#xD;
             stratified by age and gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individulas aged under 18 years.&#xD;
&#xD;
          -  Subjects who do not sign the informed consent.&#xD;
&#xD;
          -  Subjects that due to different conditions (physical, mental or social) is expected&#xD;
             that do not complete the expected follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gustavo C Rodriguez-Roca, MD, PhD</last_name>
    <phone>608293478</phone>
    <email>gcrodriguezroca@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Avenida de Irlanda, 12, 2º A</name>
      <address>
        <city>Toledo</city>
        <zip>45005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gustavo C Rodriguez-Roca, MD, PhD</last_name>
      <phone>608293478</phone>
      <email>gcrodriguezroca@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Francisco J Alonso-Moreno, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alejandro Villarin-Castro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio Segura-Fragoso, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luis Rodriguez-Padial, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juan Fernandez-Martin, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carlos Escobar-Cervantes, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>28869129</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>28566229</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24646328</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24034757</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>28284813</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Castilla-La Mancha Health Service</investigator_affiliation>
    <investigator_full_name>Gustavo Rodriguez Roca</investigator_full_name>
    <investigator_title>Director &amp; principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Dyslipidemia</keyword>
  <keyword>Smoking</keyword>
  <keyword>Cardiovascular</keyword>
  <keyword>Toledo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294369
org study id: RICARTO
nct id: NCT03294369
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Assess cardiovascular risk of the study population
time frame: December 2020
description: Cardiovascular risk will be determined according to SCORE scale calibrated for Spanish population and the Framingham Heart Study scale.
measure: Prevalence of cardiovascular risk factors
time frame: December 2020
description: To assess the prevalence of cardiovascular risk factors
measure: Prevalence of cardiovascular disease
time frame: December 2020
description: To assess the prevalence of cardiovascular disease
arm group label: Cohort of the study
description: A sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender.
intervention type: Other
intervention name: Observational
description: This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.
arm group label: Cohort of the study
Total blood and serum samples will be frozen (-85ºC) for future genetic studies.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gustavo C Rodriguez-Roca, MD, PhD
phone: 608293478
email: gcrodriguezroca@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
citation: 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: 28869129
citation: 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: 28566229
citation: 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: 24646328
citation: 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: 24034757
citation: 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: 28284813
responsible party type: Principal Investigator
investigator affiliation: Castilla-La Mancha Health Service
investigator full name: Gustavo Rodriguez Roca
investigator title: Director & principal Investigator, Clinical Professor
mesh term: Cardiovascular Diseases
sharing ipd: Undecided