{"doc_desc":{"title":"Pr\u00e9valence de l'Amylose \u00e0 transthyr\u00e9tine dans les cardiopathies hypertrophiques","idno":"FRESH-PEF8655-fr","producers":[{"name":"Genevi\u00e8ve MULAK","affiliation":"SOC FRANCAISE DE CARDIOLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8655-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8655"},{"agency":"FReSH","code":"FRESH-PEF8655"}]},"title":"Pr\u00e9valence de l'Amylose \u00e0 transthyr\u00e9tine dans les cardiopathies hypertrophiques","alternate_title":"AMYLO-STUDY"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Thibaud;DAMY","PILabo":"CHU Henri-Mondor \/ Groupe Hospitalier HENRI MONDORALBERT CHENEVIER","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0003-4058-3848","role":"pi id"},{"title":"IdRef","uri":"089284224","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"amylo@sfcardio.fr","isContact":"Oui"},{"type":"investigator","name":"Violaine;PLANTE-BORDENEUVE","PILabo":"CHU Henri-Mondor \/ Groupe Hospitalier HENRI MONDORALBERT CHENEVIER","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-7880-2316","role":"pi id"},{"title":"IdRef","uri":"061680540","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"violaine.plante@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Michel;SLAMA","PILabo":"H\u00f4pital \/ Service Cardiologie et Maladies Vasculaires","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059808470","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"michel.slama@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSOCIATION DE SOUTIEN A LA FILIALE D'IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03vqp1c86","role":"sponsor id"},{"title":"SIREN","uri":"411962640","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSOCIATION DE SOUTIEN A LA FILIALE D'IMAGERIE CARDIOVASCULAIRE DE LA SOCIETE FRANCAISE DE CARDIOLOGIE (ASFIC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03vqp1c86"},{"title":"SIREN","uri":"411962640"}]}]},"distribution_statement":{"contact":[{"name":"Thibaud;DAMY","email":"amylo@sfcardio.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation 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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":"Amylose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2078467774","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"D\u00e9finir la pr\u00e9valence des amyloses \u00e0 TTR dans une large population de patients atteints de CMH","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2014-01-01"}],"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 (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\": \" Age sup\u00e9rieur ou \u00e9gal \u00e0 18 ans - Cardiopathie d\u00e9finie par une \u00e9paisseur \u00e9chocardiographique du ventricule gauche sup\u00e9rieure ou \u00e9gale \u00e0 13 mm si forme familiale ou sup\u00e9rieure ou \u00e9gale \u00e0 15 mm si forme sporadique - Patient ayant sign\u00e9 un consentement autorisant la prise de sang sp\u00e9cifique en vue d\u2019un s\u00e9quen\u00e7age g\u00e9n\u00e9tique \u00e0 la recherche d\u2019une anomalie du g\u00e8ne TTR.  \",\n    \"clusion_E\": \"RAC significatif (inf\u00e9rieur ou \u00e9gal \u00e0 1cm2) - Patient avec un diagnostic de la cardiomyopathie (CMH sarcom\u00e9rique, maladie de Fabry, \u2026) ou apparent\u00e9 d\u00e9j\u00e0 diagnostiqu\u00e9  Les patients inclus dans le registre REMY (Registre des cardiomyopathies hypertrophiques) peuvent \u00eatre \u00e9galement inclus dans l\u2019AMYLO-STUDY Les crit\u00e8res d\u2019inclusion sont quasi similaires Il faudra simplement compl\u00e9ter quelques donn\u00e9es compl\u00e9mentaires sur la page adoss\u00e9e \u00e0 ce registre\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\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":""}},"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":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"Objectif : 260. 298 patients inclus au 30\/04\/2014."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","conditions":"Contacter le responsable 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