{"doc_desc":{"title":"Etude cas-t\u00e9moins sur les facteurs favorisant la progression du r\u00e9trecissement aortique","idno":"FRESH-PEF60116-fr","producers":[{"name":"David MESSIKA-ZEITOUN","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60116-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60116"},{"agency":"FReSH","code":"FRESH-PEF60116"}]},"title":"Etude cas-t\u00e9moins sur les facteurs favorisant la progression du r\u00e9trecissement aortique","alternate_title":"COFRASA \/ GENERAC"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"David;MESSIKA-ZEITOUN","firstname":"David","lastname":"MESSIKA-ZEITOUN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"dmessika-zeitoun@ottawaheart.ca","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"SERVICE DE CARDIOLOGIE DU PROFESSEUR VAHANIAN","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]}]},"distribution_statement":{"contact":[{"name":"David;MESSIKA-ZEITOUN","lastname":"MESSIKA-ZEITOUN","firstname":"David","type":"contact","email":"dmessika-zeitoun@ottawaheart.ca","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"remplacement valvulaire aortique"},{"keyword":"accidents vasculaires"},{"keyword":"valve aortique"},{"keyword":"atteinte ath\u00e9roscl\u00e9reuse vasculaire"},{"keyword":"intima-media."},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"insuffisance cardiaque"},{"keyword":"infarctus du myocarde"}],"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":"St\u00e9nose de la valve aortique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/956813047","title":"CIM-11"}]}],"purpose":"D\u00e9termination des facteurs favorisant la progression du r\u00e9tr\u00e9cissement aortique en particulier l'effet des marqueurs biologiques de l'inflammation, de la coagulation et de l'agr\u00e9gation plaquettaire et des m\u00e9talloproteinases matricielles. Objectifs secondaires : - \u00c9valuer la relation entre la progression du RAC et la progression de l\u2019ath\u00e9roscl\u00e9rose vasculaire ; - Rechercher des facteurs de pr\u00e9disposition g\u00e9n\u00e9tique associ\u00e9s au RAC avec une approche g\u00e8nes candidats (Fetuine-A, MGP et r\u00e9cepteur de la vitamine D) et des \u00e9tudes d\u2019association pan g\u00e9nomique (genomewide association) ; - \u00c9valuer la relation entre les polymorphismes identifi\u00e9s de la fetuine-A, de la MGP et du r\u00e9cepteur de la vitamine D avec 1) les taux plasmatiques de fetuine-A, de MGP, de vitamine D et de parathormone, 2) la s\u00e9v\u00e9rite h\u00e9modynamique de la st\u00e9nose et 3) la progression du RAC.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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 (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\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            \"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Groupe patients (r\u00e9tr\u00e9cissement aortique) - \u00e2ge sup\u00e9rieur ou \u00e9gal 18 ans ; - st\u00e9nose aortique \u00ab d\u00e9g\u00e9n\u00e9rative \u00bb, pure (insuffisance aortique absente ou minime), isol\u00e9e (absence de valvulopathie associ\u00e9e de grade sup\u00e9rieure ou \u00e9gale 2\\\/4) ; - absence d\u2019insuffisance r\u00e9nale s\u00e9v\u00e8re connue (clairance de la cr\u00e9atinine inf\u00e9rieur \u00e0 30 ml \\\/ min) ; - patients b\u00e9n\u00e9ficiant d\u2019un r\u00e9gime de s\u00e9curite sociale.  Groupe contr\u00f4le  - \u00e2ge sup\u00e9rieur ou \u00e9gal \u00e0 18 ans ; - absence de lien de parent\u00e9 biologique au premier degr\u00e9 avec un patient pr\u00e9sentant une st\u00e9nose aortique ; - absence de valvulopathie de grade sup\u00e9rieure ou \u00e9gale 2\\\/4 ; - absence d\u2019insuffisance r\u00e9nale s\u00e9v\u00e8re connue (clairance de la cr\u00e9atinine inf\u00e9rieure \u00e0 30 ml \\\/ min) ; - patients b\u00e9n\u00e9ficiant d\u2019un r\u00e9gime de s\u00e9curit\u00e9 sociale.\",\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) : Exploration fonctionnelle']","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 vers le patient et\/ou retour vers un tiers. Relance des sujets pour r\u00e9aliser les visites de suivi. Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"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\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"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":"- 1000 patients pr\u00e9sentant un r\u00e9tr\u00e9cissement aortique \/ cases - 1500 contr\u00f4les \/ controls"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"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 : ouverte \u00e0 des projets ancillaires, r\u00e9plication d\u2019\u00e9tudes g\u00e9n\u00e9tiques. Utilisation impossible des donn\u00e9es par des industriels.","conditions":"","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23768690"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier avec double saisie. Examens cliniques : \u00e9tape manuscrite avec double saisie. Examens biologiques : \u00e9tape manuscrite avec double saisie.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"\u00cele-de-France"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi (annuellement) Informations recueillies : - poids, - tension art\u00e9rielle (TA), - p\u00e9rim\u00e8tre abdominal, - \u00e9lectrocardiogramme (ECG), - auscultation.","biologicalDataDetails":"Sang (+ valve aortique chez les patients op\u00e9r\u00e9s)","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}