{"doc_desc":{"title":"Cohorte de patients ayant fait un SCA dans l\u2019ann\u00e9e : \u00e9valuation en ambulatoire de la valeur pronostique de l\u2019AOMI diagnostiqu\u00e9e par la clinique ou par la mesure de l\u2019IPS","idno":"FRESH-PEF137-fr","producers":[{"name":"Nathalie SCHMIDELY","affiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF137-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"137"},{"agency":"FReSH","code":"FRESH-PEF137"}]},"title":"Cohorte de patients ayant fait un SCA dans l\u2019ann\u00e9e : \u00e9valuation en ambulatoire de la valeur pronostique de l\u2019AOMI diagnostiqu\u00e9e par la clinique ou par la mesure de l\u2019IPS","alternate_title":"CALIPSO"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Marie-Annick;HERRMANN","PILabo":"Bristol-Myers Squibb","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"380059956","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"marie-annick.herrmann@bms.com","isContact":"Oui"},{"type":"investigator","name":"Nathalie;SCHMIDELY","PILabo":"Bristol-Myers Squibb","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"380059956","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229","role":"sponsor id"},{"title":"SIREN","uri":"380059956","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]}]},"distribution_statement":{"contact":[{"name":"Marie-Annick;HERRMANN","email":"marie-annick.herrmann@bms.com","type":"contact","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/013b57229","role":"organisation id","title":"ROR"},{"uri":"380059956","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"AOMI"},{"keyword":"IPS"},{"keyword":"valeur pronostique"},{"keyword":"\u00e9v\u00e9nements isch\u00e9miques"},{"keyword":"Cardiologie"},{"keyword":"SCA"},{"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":"Maladie microvasculaire coronarienne","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1752457658","title":"CIM-11"}]},{"topic":"Atteintes des art\u00e8res, art\u00e9rioles et capillaires au cours de maladies class\u00e9es ailleurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1833474936","title":"CIM-11"}]}],"purpose":"D\u00e9terminer la valeur pronostique de AOMI (symptomatique ou asymptomatique) sur la survenue d\u2019\u00e9v\u00e9nements isch\u00e9miques (d\u00e9c\u00e8s, r\u00e9cidive isch\u00e9mique myocardique, accident vasculaire c\u00e9r\u00e9bral (AVC), revascularisation, rehospitalisation pour \u00e9v\u00e9nements isch\u00e9miques) chez des patients ayant eu un SCA r\u00e9cent.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2009-01-01"}],"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\": \"Partie Registre : patient H\\\/F adulte, vu en consultation de cardiologie lib\u00e9rale, ayant un ant\u00e9c\u00e9dent de SCA avec ou sans sus d\u00e9calage du segment ST dans les 12 derniers mois. Partie Etude : patients du registre (2 premiers pts cons\u00e9cutifs du registre sans AOMI) + ( 2 premiers patients cons\u00e9cutifs du registre avec AOMI (symptomatique ou asymptomatique) et IPS inf\u00e9rieur \u00e0 0.9)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","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\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Cluster\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : grappe\"}']","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":"[1000-10000[ individus","response_rate":"Registre\/register : 2883 Cohorte\/cohort :1760"},"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":"","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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":"Non","contributorName":"Marie-Annick HERRMANN","contributorAffiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Industrie"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Cahiers d'observation papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"glyc\u00e9mie \u00e0 jeun,cr\u00e9atinin\u00e9mie, h\u00e9moglobine glyqu\u00e9e, chol total, HDL, LDL, triglyc\u00e9rides","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}