{"doc_desc":{"title":"Prospective evaluation of Autonomic Nervous System (ANS) as a prognostic indicator of cardiovascular and cerebrovascular event in a cohort","idno":"FRESH-PEF3650-en","producers":[{"name":"Jean-Claude BARTHELEMY","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3650-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3650"},{"agency":"FReSH","code":"FRESH-PEF3650"}]},"title":"Prospective evaluation of Autonomic Nervous System (ANS) as a prognostic indicator of cardiovascular and cerebrovascular event in a cohort","alternate_title":"PROOF"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Jean-Claude;BARTHELEMY","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE \/ Laboratoire SNA-EPIS EA4607 (Syst\u00e8me nerveux Autonome - Epid\u00e9miologie, Physiologie, Ing\u00e9nierie, Sant\u00e9)Service de Physiologie Clinique du CHU de St EtienneUniversit\u00e9 Jean Monnet - PRES Lyon","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ORCID","uri":"0000-0003-4306-7275","role":"pi id"},{"title":"IdRef","uri":"030974895","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"RNSR","uri":"199113115Z","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Fred\u00e9ric;ROCHE","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE DE \/ Laboratoire SNA-EPIS EA4607 (Syst\u00e8me nerveux Autonome - Epid\u00e9miologie, Physiologie, Ing\u00e9nierie, Sant\u00e9)Service de Physiologie Clinique du CHU de St EtienneUniversit\u00e9 Jean Monnet - PRES Lyon","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"08983142X","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"RNSR","uri":"199113115Z","role":"labo id"}],"email":"frederic.roche@univ-st-etienne.fr","isContact":"Yes"}],"oth_id":[{"name":"Other related cohorts: 1) Also in charge of the analysis of the activity of ANS in the Sapaldia cohort (Swiss cohort study on air pollution and lung diseases in adults). 2) Aube cohort: ANS evolution after normal or premature birth and cognitive evolution.","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"UNIVERSITE DE LYON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01rk35k63","role":"sponsor id"}],"role":"sponsor"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"sponsor id"},{"title":"SIREN","uri":"264200304","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE JEAN MONNET (EPSCP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/030bahv93","role":"sponsor id"},{"title":"SIREN","uri":"938501681","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Fred\u00e9ric;ROCHE","email":"frederic.roche@univ-st-etienne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id","title":"ROR"},{"uri":"264200304","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"autonomic nervous system (ANS)"},{"keyword":"heart rate variability"},{"keyword":"baroreflex"},{"keyword":"blood pressure variability"},{"keyword":"Prevention"},{"keyword":"epidemiology"},{"keyword":"sleep"}],"topics":[{"topic":"Cardiology and vascular medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"Geriatrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]},{"topic":"Neurology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"Evaluate on a prospective basis the predictive value of ANS activity, and its decline during the follow-up, on the occurrence of serious cerebral events, and on mortality all cause considered, in a general population of homogeneous age, 65 at inclusion. Secondary objectives have been defined, analyzing the association between ANS and: 1) The presence and severity of cerebrovascular accidents at NRM imaging; 2) Neuropsychological performances; 3) Classic cardiovascular risk factors; 4) Genetic of the specific receptors of the neurotransmitters directly implied; 5) Sleep respiratory pathologies; 6) Realization of temporal analysis to determine chronological sequences of the decline of ANS activity and pathological conditions occurrence, including emerging conditions, such as sleep respiratory pathologies.","abstract":"","coll_dates":[{"start":"2001-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"65 ages old subjects  at inclusion, and registered on the electoral lists of the city of St.Etienne.  - Subjects who did not have a myocardial infarction or a preceding cerebrovascular accident.  - Subjects not insulin-dependent\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Anthropometry']","quality_statement":{"standards":[{"name":"['Coherence request after computer data entry. Missing data checked back to the original file or asked back to the patient or a third. Doctors and Subjects remainders for follow-up visits. Internal and external quality audit reports. Internal audit frequency: Statistics, by data themes. External audit frequency: 3. Patients receive information about the use of their data.']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1011"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data utilization possible for academic teams. Data utilization available for industrials.","conditions":"Submit a demand to the director of the SNA-EPIS team. Decision by the steering committee. Contractual access condition: contact the main investigator or a co-investigator. Access condition: contact the main investigator.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"15-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"16-12-2019","isContributorPI":"No","contributorName":"Fred\u00e9ric ROCHE","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Public (France)"],"otherSponsorType":["","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data have been collected during 5 check-ups, check-ups 1 and 4 are completed, check-ups 2, 3 and 5 are partials (neither cerebral NRM nor neuropsychological check).Clinical data collected concern: - Neuropsychological check analyzing memory, executive and dysexecutive functions (GROBER, BENTON, DSST, BADDELEY, TMT, STROOP, FLUENCIES, WAIS, MMSE)- Depression (QD2A)- Anxiety (GOLDBERG)- Ambulatory blood pressure monitoring, MAPA- HOLTER ECG- Elasticity of arterial walls- Baroreflex- Genetic check- Questionnaire on the existence and severity of restless legs syndrome- Sleep quality questionnaire: St. Mary\u2019s hospital and PittsburgSelf-questionnaire data concern:- Evaluation of daily physical activity- Sleep quality (BERLIN, EPWORTH)- Life quality- Urinary disorders (DITROVIE, MHU)Data collected through the interview concern family and personal history (age of menopause, cardiovascular history, personal history, family history, treatments in progress, weight, height, waist\/hips circumference, stature, tobacco, alcohol habitudes)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"City of Saint-Etienne"},"dataTypes":{"clinicalDataDetails":"Clinical examination at inclusion and every 2 years during the follow-up. Information collected through the clinical examination: 1) School data 2) Neuropsychological check: - Grober and Buschke; - Benton; - Digit substitution st; - Baddeley's dual task; -Trail marking test; - Stroop; - Wais; - MMSE; 3) Depression (QD2A) 4) Anxiety (Goldberg) 5) Sleep: St. Mary's hospital questionnaire 6) Sleep: Pittsburg questionnaire","biologicalDataDetails":"Blood biology: classic cardiovascular risk factors, inflammation markers, hormones, vitamin D","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}