{"doc_desc":{"title":"Cohorte en population g\u00e9n\u00e9rale: Evaluation Prospective de l'activit\u00e9 du Syst\u00e8me Nerveux Autonome (SNA) comme indicateur pronostic d'\u00e9v\u00e8nements cardiovaculaires et c\u00e9r\u00e9brovasculaires","idno":"FRESH-PEF3650-fr","producers":[{"name":"Jean-Claude BARTHELEMY","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3650-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3650"},{"agency":"FReSH","code":"FRESH-PEF3650"}]},"title":"Cohorte en population g\u00e9n\u00e9rale: Evaluation Prospective de l'activit\u00e9 du Syst\u00e8me Nerveux Autonome (SNA) comme indicateur pronostic d'\u00e9v\u00e8nements cardiovaculaires et c\u00e9r\u00e9brovasculaires","alternate_title":"PROOF"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Non"},{"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":"Oui"}],"oth_id":[{"name":"Autres cohortes apparent\u00e9es : 1) egalement en charge de l\u2019analyse de l\u2019activite du sna dans la cohorte sapaldia (swiss cohort study on air pollution and lung diseases in adults). 2\u00b0 cohorte aube : evolution du sna apres la naissance normale ou prematuree et evolution cognitive.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"activit\u00e9 du Syst\u00e8me Nerveux Autonome (SNA)"},{"keyword":"variabilit\u00e9 de la fr\u00e9quence cardiaque"},{"keyword":"baror\u00e9flexe"},{"keyword":"variabilit\u00e9 de la pression art\u00e9rielle"},{"keyword":"pr\u00e9vention"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"sommeil"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","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":"G\u00e9riatrie","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":"Neurologie","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":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Evaluer de fa\u00e7on prospective la valeur pr\u00e9dictive de l'activit\u00e9 du Syst\u00e8me Nerveux Autoniome (SNA) , et de son d\u00e9clin au cours du suivi, sur la survenue d'\u00e9v\u00e8nements graves et c\u00e9r\u00e9braux, et sur la mortalit\u00e9 toutes causes confondues, dans une population g\u00e9n\u00e9rale de sujets d'\u00e2ge homog\u00e8ne, 65 ans \u00e0 l'inclusion. Des objectifs secondaires sont d\u00e9finis, analysant l'association entre activit\u00e9 du SNA et: 1) La pr\u00e9sence et la s\u00e9v\u00e9rit\u00e9 des accidents vasculaires c\u00e9r\u00e9braux \u00e0 l\u2019IRM, 2) Les performances neuropsychologiques, 3) Les facteurs de risques cardiovasculaires classiques, 4) La g\u00e9n\u00e9tique des r\u00e9cepteurs sp\u00e9cifiques des neurotransmetteurs directement impliqu\u00e9s, 5) Les pathologies respiratoires du sommeil 6) Il sera r\u00e9salis\u00e9 des analyses temporelles pour d\u00e9terminer les s\u00e9quences chronologiques du d\u00e9clin de l'activit\u00e9 du SNA et de la survenue de conditions pathologiques, y compris des conditions \u00e9mergentes telles que les pathologies respiratoires du sommeil.","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":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Sujets \u00e2g\u00e9s de 65 ans au moment de l'inclusion et inscrits sur la liste \u00e9lectorale de la ville de St Etienne. - Sujets n'ayant pas eu d'infarctus du myocarde ou d'accident vasculaire c\u00e9r\u00e9bral pr\u00e9alable - Sujet non insulino-d\u00e9pendant\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","quality_statement":{"standards":[{"name":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient ou retour vers un tiersRelance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits qualit\u00e9 internes et externes Fr\u00e9quence audit interne : STATISTIQUES, PAR THEMES DE DONNEES Fr\u00e9quence audit externe : 3 Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1011"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Demande au Directeur de l'\u00e9quipe SNA-EPIS. D\u00e9cision par le comit\u00e9 Directeur. Condition d'acc\u00e8s contractuelles pour les \u00e9quipes acad\u00e9miques : prendre contact avec l'investigateur principal ou avc son coinvestigateur Condition d'acc\u00e8s pour les industriels : prendre contact avec l'investigateur principal. contrats de valorisation.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"15-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"16-12-2019","isContributorPI":"Non","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":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es ont \u00e9t\u00e9 et seront recueilleis au cours de 5 bilans, les bilans 1 et 4 sont complets et les bilans 2, 3 et 5 sont partiels ( c'est \u00e0 dire pas d'IRM c\u00e9r\u00e9bral ni de bilan neuropsychologique).Les donn\u00e9es cliniques recueillies concernent:-Bilan neuropsychologique analysant la m\u00e9moire, et les fonctions \u00e9xecutives et dysexecutives(GROBER, BENTON, DSST, BADDELEY, TMT, STROOP, FLUENCIES, WAIS, MMSE)- D\u00e9pression (QD2A)- Anxi\u00e9t\u00e9 (GOLDBERG)- Mesure ambulatoire de la pression art\u00e9rielle, MAPA- HOLTER ECG- Elasticit\u00e9 art\u00e9rielle- Baror\u00e9flexe- Bilan g\u00e9n\u00e9tique- Questionnaire sur l'existence et la s\u00e9v\u00e9rit\u00e9 des jambes sans repos- Questionnaire de qualit\u00e9 du sommeil: St Mary's hospital, et PittsburgLes donn\u00e9es de l'autoquestionnaire concernent:- Evaluation de l'activit\u00e9 physique quotidienne,- Qualit\u00e9 du sommeil (BERLIN, EPWORTH)- Qualit\u00e9 de vie,- Troubles urinaires (DITROVIE, MHU)Les donn\u00e9es recueillies au cours de l'entretien concernent l'histoire familiale et personnelle ( \u00e2ge de la m\u00e9nopause, ant\u00e9c\u00e9dents cardiovasculaires, ant\u00e9c\u00e9dents familiaux, ant\u00e9c\u00e9dents personnels, traitements en cours, poids, taille, tour de taille, tour de hanche, envergure, habitudes tabac et alcool)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Ville de Staint-Etienne"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les deux ansInformations recueillies lors de l'examen clinique : 1) Donn\u00e9es scolaires2) Bilan neuropsychologique :- Grober et Buschke ;- Benton ;- digit substitution st ; - double tache de Baddeley ;- trail making test ;- stroop ;- fluences ;- wais ;- MMSE.3) D\u00e9pression (QD2A)4) Anxi\u00e9t\u00e9 (Goldberg)5) Sommeil : questionnaire de St Mary\u2019s hospital6) Sommeil : questionnaire de Pittsburg","biologicalDataDetails":"Biologie sanguine: Facteurs de risques cardiovasculaires classiques, marqueurs de l'inflammation, hormones, vitamine D","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}