{"doc_desc":{"title":"Cohorte de patients de plus 45 ans ayant pr\u00e9sent\u00e9 un infarctus du myocarde, un angor instable ou un accident vasculaire c\u00e9r\u00e9bral de type isch\u00e9mique: \"SUppl\u00e9mentation en FOlates, en vitamine B6, en vitamine B12 et\/ou en acides gras poly-insatur\u00e9s OM\u00e9ga-3\"","idno":"FRESH-PEF3319-fr","producers":[{"name":"Serge HERCBERG","affiliation":"UNIVERSITE SORBONNE PARIS NORD"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3319-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3319"},{"agency":"FReSH","code":"FRESH-PEF3319"}]},"title":"Cohorte de patients de plus 45 ans ayant pr\u00e9sent\u00e9 un infarctus du myocarde, un angor instable ou un accident vasculaire c\u00e9r\u00e9bral de type isch\u00e9mique: \"SUppl\u00e9mentation en FOlates, en vitamine B6, en vitamine B12 et\/ou en acides gras poly-insatur\u00e9s OM\u00e9ga-3\"","alternate_title":"SU.FOL.OM3"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Pilar;GALAN","PILabo":"Inserm, INRA, CNAM, universit\u00e9 Paris 13 \/ Equipe de Recherche en Epid\u00e9miologie Nutritionnele (EREN), U1153 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","affiliationName":"UNIVERSITE SORBONNE PARIS NORD","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"03244043X","role":"pi id"},{"title":"SIREN","uri":"199312380","role":"organisation id"},{"title":"RNSR","uri":"201420738K","role":"labo id"}],"email":"p.galan@eren.smbh.univ-paris13.fr","isContact":"Oui"},{"type":"investigator","name":"Serge;HERCBERG","PILabo":"Inserm, INRA, CNAM, universit\u00e9 Paris 13 \/ Equipe de Recherche en Epid\u00e9miologie Nutritionnele (EREN), U1153 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne 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id"}],"role":"sponsor"},{"name":"UNIVERSITE SORBONNE PARIS NORD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0199hds37","role":"sponsor id"},{"title":"SIREN","uri":"199312380","role":"sponsor id"}],"role":"sponsor"},{"name":"CONSERVATOIRE NATIONAL DES ARTS ET METIERS (CNAM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0175hh227","role":"sponsor id"},{"title":"SIREN","uri":"197534713","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CANDIA (C.SAS)","extlink":[{"title":"SIREN","uri":"352014955"}]},{"name":"DANONE","extlink":[]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Pilar;GALAN","email":"p.galan@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE SORBONNE PARIS NORD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0199hds37","role":"organisation id","title":"ROR"},{"uri":"199312380","role":"organisation id","title":"SIREN"}]},{"name":"Serge;HERCBERG","email":"s.hercberg@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE SORBONNE PARIS NORD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0199hds37","role":"organisation id","title":"ROR"},{"uri":"199312380","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"maladies cardiovascualires (MCV)"},{"keyword":"accident vasculaire c\u00e9r\u00e9bral (AVC)"},{"keyword":"essai randomis\u00e9"},{"keyword":"pr\u00e9vention secondaire"}],"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":"Cardiopathies isch\u00e9miques","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1964269418","title":"CIM-11"}]},{"topic":"Maladies de l'appareil circulatoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/426429380","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectifs principaux : v\u00e9rifier l'hypoth\u00e8se de l'int\u00e9r\u00eat d'un apport suppl\u00e9mentaire en folates (et en vitamines B6 ou B12) et\/ou en om\u00e9ga-3 dans la pr\u00e9vention de la r\u00e9cidive de pathologies isch\u00e9miques chez les sujets coronariens av\u00e9r\u00e9s ou ayant pr\u00e9sent\u00e9 un accident vasculaire c\u00e9r\u00e9bral. Objectif secondaire: \u00e9valuer le r\u00f4le de certaines mutations g\u00e9n\u00e9tiques dans l'aptitude de la suppl\u00e9mentation \u00e0 r\u00e9duire le risque de maladies cardiovasculaires.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Sujets \u00e2g\u00e9s de 45 \u00e0 80 ans, ayant pr\u00e9sent\u00e9 un infarctus du myocarde, un angor instable ou un accident vasculaire c\u00e9r\u00e9bral de type isch\u00e9mique dans la p\u00e9riode pr\u00e9c\u00e9dant leur inclusion (\u00e9v\u00e8nement survenu au minimum un mois et au maximum un an avant l'inclusion).  \",\n    \"clusion_E\": \"les sujets devant suivre un traitement par la B12, l'acide folique, ou la B6, les sujets suivant un traitement par m\u00e9thotrexate, les sujets porteurs d'une pathologie non cardiovasculaire mettant en jeu leur pronostic vital sur les 5 ann\u00e9es de l'\u00e9tude, les sujets insuffisants r\u00e9naux chroniques s\u00e9v\u00e8res\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Relance des sujets pour r\u00e9aliser les visites de suivi.R\u00e9alisation d\\'un audit de qualit\u00e9 interneLes patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"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"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"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[ 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industriels","conditions":"Contrat","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":"30-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"Non","contributorName":"Serge HERCBERG","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/SUFOLOM3"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Industrie","Public (France)","Industrie","Public (France)","Industrie","Priv\u00e9 \u00e0 but non 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Tous les \u00e9v\u00e9nements concernant l'\u00e9tat de sant\u00e9 des sujets (modifications de la th\u00e9rapeutiques, hospitalisations, interventions chirurgicales, r\u00e9cidives, d\u00e9c\u00e8s, ...) sont recueillis lors des rendez-vous annuels dans les centres locaux d'accueil SU.FOL.OM 3 ou gr\u00e2ce \u00e0 des questionnaires bi-annuels ; des compl\u00e9ments d'informations sont aussi obtenus gr\u00e2ce \u00e0 des questionnaires bi-annuels ; des compl\u00e9ments d'informations sont aussi obtenus gr\u00e2ce aux m\u00e9decins g\u00e9n\u00e9ralistes ou sp\u00e9cialistes ayant en chanrge les patients.Donn\u00e9es recueillies par :- autoquestionnaire : (1) \u00e9v\u00e8nements de sant\u00e9, \u00e9volution de certains facteurs de risques et habitudes de vie, (2) questionnaire alimentaire.- examen clinique : tension art\u00e9rielle, examen clinique centr\u00e9 sur la pathologie, anthropom\u00e9trie- informations communiqu\u00e9es par un tiers sur les \u00e9v\u00e8nements de sant\u00e9 cardiovasculaires ou neurovasculaires survenus","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi (tous les ans)Informations recueillies lors de l'examen clinique : tension art\u00e9rielle, examen clinique centre sur la pathologie, anthropom\u00e9trie","biologicalDataDetails":"Sang : taux d'homocystein\u00e9mie plasmatique, vitamine B12 plasmatique, de phosphate de pyridoxal plasmatiques, de folates plasmatiques et \u00e9rythrocytaires, polymorphisme g\u00e9n\u00e9tique du g\u00e8ne qui code pour MTHFR, bilan lipidique et glyc\u00e9mie.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}