{"doc_desc":{"title":"Cohorte Karolinska-Rennes: asynchronisme cardiaque chez les patients insuffisants cardiaque \u00e0 fraction d'\u00e9jection pr\u00e9serv\u00e9e","idno":"FRESH-PEF8678-fr","producers":[{"name":"Genevi\u00e8ve MULAK","affiliation":"SOC FRANCAISE DE CARDIOLOGIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8678-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8678"},{"agency":"FReSH","code":"FRESH-PEF8678"}]},"title":"Cohorte Karolinska-Rennes: asynchronisme cardiaque chez les patients insuffisants cardiaque \u00e0 fraction d'\u00e9jection pr\u00e9serv\u00e9e","alternate_title":"KaRen"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Jean-Claude;DAUBERT","PILabo":"CHU \/ Centre Cardio-Pneumologique, H\u00f4pital Pontchaillou, CHU de Rennes","affiliationName":"chu","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"060362650","role":"pi 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(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":"Jean-Claude;DAUBERT","email":"jean-claude.daubert@chu-rennes.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id","title":"ROR"}]},{"name":"Erwan;DONAL","email":"erwan.donal@chu-rennes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE RENNES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qec5a53","role":"organisation id","title":"ROR"}]}]},"study_info":{"keywords":[{"keyword":"IC"},{"keyword":"HF"},{"keyword":"Heart Failure"},{"keyword":"arythmie atriale"},{"keyword":"fraction d'\u00e9jection ventriculaire gauche"},{"keyword":"LVEF."},{"keyword":"pronostic"},{"keyword":"pr\u00e9valence"}],"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"}]}],"purpose":"L'objectif principal est de tester la valeur pronostique de l'asynchronisme cardiaque m\u00e9canique ou \u00e9lectrique, sa pr\u00e9valence et ses caract\u00e9ristiques chez des patients insuffisants cardiaques \u00e0 fraction d'\u00e9jection ventriculaire gauche pr\u00e9serv\u00e9e.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2012-01-01"}],"nation":[{"name":"Su\u00e8de","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}},{"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\": \" Visite OU hospitalisation pour sympt\u00f4me d\u2019Insuffisance cardiaque - Signes cliniques d\u2019IC : IC si, selon les crit\u00e8res de Framingham : 2 crit\u00e8res majeurs ou 1 crit\u00e8re majeur + 2 mineurs - LVEF (Left Ventricular Ejection Fraction) sup\u00e9rieure ou \u00e9gale \u00e0 45% par \u00e9chographie cardiaque - NT-pro BNP sup\u00e9rieur \u00e0 300 pg\\\/ml ou BNP sup\u00e9rieur \u00e0 100  \",\n    \"clusion_E\": \"Cardiomyopathie hypertrophique primitive document\u00e9e, ou restrictive, ou maladie syst\u00e9mique connue pour \u00eatre associ\u00e9e avec une pathologie infiltrante du coeur - IC droite explicable par une atteinte pulmonaire ou art\u00e9rielle pulmonaire sans participation du coeur gauche - Constriction p\u00e9ricardique - Bronchopneumopathie restrictive ou obstructive attest\u00e9e par la n\u00e9cessit\u00e9 d\u2019oxyg\u00e8ne \u00e0 domicile - Phase terminale de maladie r\u00e9nale, n\u00e9cessitant dialyse - Pacemaker bi-ventriculaire (CRT-P + DAI) - Syndrome Coronaire Aigu\"\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) : 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\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":"['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\"}","{\"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":"< 500 individus","response_rate":"362 (mai 2012)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study 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