Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-23 @ 12:02 AM
Study NCT ID:
NCT03294369
Status:
UNKNOWN
Last Update Posted:
2020-01-29
First Post:
2017-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk in Toledo Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Total blood and serum samples will be frozen (-85ºC) for future genetic studies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3125}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess cardiovascular risk of the study population', 'timeFrame': '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', 'timeFrame': 'December 2020', 'description': 'To assess the prevalence of cardiovascular risk factors'}, {'measure': 'Prevalence of cardiovascular disease', 'timeFrame': 'December 2020', 'description': 'To assess the prevalence of cardiovascular disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes', 'Dyslipidemia', 'Smoking', 'Cardiovascular', 'Toledo'], 'conditions': ['Cardiovascular Risk Factor', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '28869129', 'type': 'RESULT', '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': '28566229', 'type': 'RESULT', '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': '24646328', 'type': 'RESULT', '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': '24034757', 'type': 'RESULT', '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': '28284813', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nClinical history, physical examination and complementary tests are being performed.\n\nTotal 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.\n\nCVR is assessed by SCORE scale calibrated for Spanish population and the Framingham Heart Study scale.\n\nPatients will be periodically visited, with a minimum follow-up of 5 years. Standard statistical analysis will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender\n\nExclusion Criteria:\n\n* Individulas aged under 18 years.\n* Subjects who do not sign the informed consent.\n* Subjects that due to different conditions (physical, mental or social) is expected that do not complete the expected follow-up.'}, 'identificationModule': {'nctId': 'NCT03294369', 'acronym': 'RICARTO', 'briefTitle': 'Cardiovascular Risk in Toledo Population', 'organization': {'class': 'OTHER', 'fullName': 'Castilla-La Mancha Health Service'}, 'officialTitle': 'RIesgo CARdiovascular y Eventos Cardiovasculares en la población General Del área Sanitaria de TOledo', 'orgStudyIdInfo': {'id': 'RICARTO'}}, 'armsInterventionsModule': {'armGroups': [{'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.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.', 'armGroupLabels': ['Cohort of the study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45005', 'city': 'Toledo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gustavo C Rodriguez-Roca, MD, PhD', 'role': 'CONTACT', 'email': 'gcrodriguezroca@gmail.com', 'phone': '608293478'}, {'name': 'Francisco J Alonso-Moreno, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alejandro Villarin-Castro, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antonio Segura-Fragoso, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luis Rodriguez-Padial, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juan Fernandez-Martin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carlos Escobar-Cervantes, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Avenida de Irlanda, 12, 2º A', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'centralContacts': [{'name': 'Gustavo C Rodriguez-Roca, MD, PhD', 'role': 'CONTACT', 'email': 'gcrodriguezroca@gmail.com', 'phone': '608293478'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}, 'collaborators': [{'name': 'Castile-La Mancha Government (Socio-Sanitary Foundation of Castile-La Mancha)', 'class': 'UNKNOWN'}, {'name': 'SEMERGEN (Spanish Society of Primary Care Physicians)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director & principal Investigator, Clinical Professor', 'investigatorFullName': 'Gustavo Rodriguez Roca', 'investigatorAffiliation': 'Castilla-La Mancha Health Service'}}}}