{"doc_desc":{"title":"\u00c9valuation de l'efficacit\u00e9 d'un protocole de r\u00e9adaptation cardiaque pr\u00e9coce chez les patients post-infarctus du myocarde","idno":"FReSH-83175-fr","producers":[{"name":"Mohamed Lajimi","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FReSH-83175-fr","IDno":{"metadata_no":[{"agency":"","code":""}],"metadata_yes":[{"code":"FReSH","agency":"FReSH"}]},"title":"\u00c9valuation de l'efficacit\u00e9 d'un protocole de r\u00e9adaptation cardiaque pr\u00e9coce chez les patients post-infarctus du myocarde","alternate_title":"Acronyme de l'\u00e9tude\r\n"},"study_authorization":{"agency":[{"name":"ANSM"},{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Camille;HUNSINGER","firstname":"Camille","lastname":"HUNSINGER","type":"investigator","extlink":[{"title":"ORCID","uri":"","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"SIREN","uri":"750775660","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"contact@impactgroup.tech","affiliationName":"ABBVIE","PILabo":"Affiliation(s), d\u00e9tails\n","isContact":true},{"name":"PHARM;10","firstname":"PHARM","lastname":"10","type":"investigator","extlink":[{"title":"ORCID","uri":"","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"SIREN","uri":"602950206","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"pharm10@impact-dev.tn","affiliationName":"ABBOTT FRANCE","PILabo":"","isContact":false},{"name":"Respsi;8","firstname":"Respsi","lastname":"8","type":"investigator","extlink":[{"title":"ORCID","uri":"","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"SIREN","uri":"428445696","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"respsi8@impact-dev.tn","affiliationName":"AEPEI (ASSOCIATION POUR L'ETUDE ET LA PREVENTION DES L'ENDOCARDITE INFECTIEUSE)","PILabo":"","isContact":""}],"oth_id":[{"name":";","firstname":"","lastname":"","type":"contributor","isContact":"","extlink":[{"title":"ORCID","uri":"","role":"team member id"},{"title":"IdRef","uri":"","role":"team member id"}]},{"name":"","type":"affiliation","teamMemberLabo":"","extlink":[{"title":"RNSR","uri":"","role":"labo id"}]},{"name":"","type":"collaboration"}],"production_statement":{"prod_place":"France Recherche en Sant\u00e9 Humaine (FReSH)","producers":[{"name":"ABBOTT FRANCE","role":"sponsor","extlink":[{"title":"SIREN","uri":"602950206","role":"sponsor id"},{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64","role":"sponsor id"}]}],"funding_agencies":[{"name":"ABBVIE","extlink":[{"title":"SIREN","uri":"750775660"}]},{"name":"ABBOTT FRANCE","extlink":[{"title":"SIREN","uri":"602950206"},{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"}]}]},"distribution_statement":{"contact":[{"name":"Tohmas;Martin","lastname":"Martin","firstname":"Tohmas","type":"contact","email":"med8@impact-dev.tn","affiliationName":"ABBVIE","contactPointLabo":"Affiliation(s), pr\u00e9cisions\n","extlink":[{"title":"SIREN","uri":"750775660","role":"organisation id"},{"title":"RNSR","uri":"000000000A","role":"labo id"}]},{"name":"Prenom;NOM","lastname":"NOM","firstname":"Prenom","type":"contact","email":"pharm10@impactd-dev.tn","affiliationName":"ABBOTT FRANCE","contactPointLabo":"","extlink":[{"title":"SIREN","uri":"602950206","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]},{"name":"Camille;HUNSINGER","lastname":"HUNSINGER","firstname":"Camille","type":"contact","email":"contact@impactgroup.tech","affiliationName":"ABBVIE","contactPointLabo":"Affiliation(s), d\u00e9tails\n","extlink":[{"title":"SIREN","uri":"750775660","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]}]},"study_info":{"keywords":[],"topics":[],"purpose":"Objectifs de l'\u00e9tude\r\n","abstract":"Cette \u00e9tude vise \u00e0 \u00e9valuer l'impact d'un programme de r\u00e9adaptation cardiaque initi\u00e9 pr\u00e9cocement (dans les 7 jours suivant l'\u00e9v\u00e9nement) sur la r\u00e9cup\u00e9ration fonctionnelle et la qualit\u00e9 de vie des patients ayant subi un infarctus du myocarde. L'\u00e9tude compare un groupe b\u00e9n\u00e9ficiant du protocole pr\u00e9coce \u00e0 un groupe suivant le parcours de soins standard, avec un suivi \u00e0 3, 6 et 12 mois portant sur la capacit\u00e9 d'effort, le taux de r\u00e9hospitalisation et l'adh\u00e9rence au traitement m\u00e9dicamenteux.","coll_dates":[{"start":"2026-09-08","end":"2027-10-08"}],"nation":[{"name":"Australie","abbreviation":"au","extLink":{"vocab":"ISO","vocabURI":"au"}},{"name":"Autriche","abbreviation":"at","extLink":{"vocab":"ISO","vocabURI":"at"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D005260\"\n            },\n            \"value\": \"F\u00e9minin\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008297\"\n            },\n            \"value\": \"Masculin\"\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D055815\"\n            },\n            \"value\": \"Adulte (19 \u00e0 24 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000328\"\n            },\n            \"value\": \"Adulte (25 \u00e0 44 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008875\"\n            },\n            \"value\": \"Adulte (45 \u00e0 64 ans)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000368\"\n            },\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\"\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion\\r\\n\",\n    \"clusion_E\": \"Crit\u00e8res d'exclusion\\r\\n\"\n}","data_kind":"['Autre']","quality_statement":{"standards":[{"name":"['Norme(s) ou nomenclature(s) utilis\u00e9es']","committee":"","governance":""}],"other_quality_statement":"['Proc\u00e9dure qualit\u00e9 mise en \u0153uvre']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Crit\u00e8re d'\u00e9valuation (de jugement) principal *\r\n"},{"activity_type":"secondary evaluation","activity_description":"Crit\u00e8re(s) d'\u00e9valuation secondaire(s)\r\n"}]},"method":{"data_collection":{"time_method":"","frequency":"Fr\u00e9quence de la collecte *\r\n","sampling_procedure":"['{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Other\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Autre']"}},"coll_mode":["{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Other\"},\"value\":\"Autre\"}"],"research_instrument":"Conditions g\u00e9n\u00e9rales relatives \u00e0 la fourniture de donn\u00e9es agr\u00e9g\u00e9es\r\n","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":[]}],"target_sample_size":"< 500 individus","response_rate":"350"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude en cours","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"Emplacement des donn\u00e9es\r\n","complete":"Exhaustivit\u00e9 des fichiers de donn\u00e9es\r\n","status":"{\"extLink\":{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_abf2\"},\"value\":\"Libre acc\u00e8s\"}","notes":""},"dataset_use":{"restrictions":"Restrictions d'acc\u00e8s\r\n","conditions":"Conditions d'acc\u00e8s aux donn\u00e9es\r\n","conf_dec":[{"txt":"Accord de confidentialit\u00e9\r\n"}],"spec_perm":[{"txt":"","required":"Non"}],"contact":[{"name":"FIrst name;LASTNAME","firstname":"FIrst name","lastname":"LASTNAME","email":"pharm10@impact-dev.tn"}],"deposit_req":"Obligation de remise des travaux\r\n","cit_req":"Exigences en mati\u00e8re de citation\r\n"}}},"additional":{"versionLang":"fr","originLang":"fr","lastUpdatedAuto":"08-09-2026","lastUpdatedManual":"08-09-2026","autoTranslation":true,"status":"Publi\u00e9e","respValidation":"","isHealthTheme":true,"isContributorPI":true,"addTeamMember":false,"primaryInvestigator":{"isPIContact":"","piMail":"respsi8@impact-dev.tn","piAffiliation":{"piLabo":""}},"relatedDocument":[{"type":"","title":"Titre du document\n","link":""}],"contactPointLabo":"Affiliation(s), d\u00e9tails\r\n","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Industrie"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":false},"collaborations":{"networkConsortium":false},"theme":{"complementaryInformation":"","RareDiseases":false},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":false,"allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[{"name":"Nom du facteur\/de l'exposition *\r\n","type":"Dispositif m\u00e9dical","typeOther":""}],"cohortLongitudinal":{"recrutementTiming":[]},"otherResearchType":{"otherResearchTypeDetails":""},"inclusionGroups":[],"nrInclusionGroups":false,"collectionProcess":{"collectionModeDetails":"Mode de collecte, pr\u00e9cisions\r\n","collectionModeOther":"Autre mode de collecte, pr\u00e9cisions\r\n"},"dataCollection":{"inclusionStrategy":[],"samplingModeOther":"Autre proc\u00e9dure d'\u00e9chantillonnage, pr\u00e9cisions\r\n","recruitmentSourceOther":"Autre source de recrutement, pr\u00e9cisions\r\n","otherDocumentation":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Port\u00e9e g\u00e9ographique, d\u00e9tails\r\n"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","biobankContent":[],"biobankContentOther":"","dataTypeOther":"Maison","paraclinicalDataOther":"","otherLiquidsDetails":""},"variableDictionnary":{"variableDictionnaryAvailable":true,"variableDictionnaryLink":"google.com"},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}},"contributorName":"Mohamed Lajimi","contributorAffiliation":""},"schematype":"survey"}