Nctid:
NCT06223906
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000006349", "term"=>"Heart Valve Diseases"}], "ancestors"=>[{"id"=>"D000006331", "term"=>"Heart Diseases"}], "browseLeaves"=>[{"id"=>"M9437", "name"=>"Heart Valve Diseases", "asFound"=>"Heart Valve Diseases", "relevance"=>"HIGH"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2016-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-01", "completionDateStruct"=>{"date"=>"2030-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2030-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"All-cause death", "timeFrame"=>"These data is collected during follow-up visit at 12 months after discharge", "description"=>"whether recidivation happened,whether other related disease happened"}], "secondaryOutcomes"=>[{"measure"=>"HF rehospitalization", "timeFrame"=>"These data is collected during follow-up visit at 12 months after discharge", "description"=>"heart failure related hospitalization within 1 years of discharge"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cardiovascular Diseases"]}, "descriptionModule"=>{"briefSummary"=>"Valvular Heart Disease, impacting 2.5% of the population, is predominantly observed in the elderly and is on the rise. The primary conditions within this category are Aortic Stenosis and Mitral Regurgitation. These conditions are linked to considerable morbidity and mortality, presenting a formidable challenge in optimizing treatment strategies. Pathophysiology of Valvular Heart Disease remains poorly known. The aim of the present study is to identify biomarkers involved in this disease using multi-omics approaches"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with heart valve disease accorrding to Inclusion and exclusion criteria.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients clinically diagnosed with heart valve disease in Beijing Anzhen Hospital\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Failure to obtain medical records and ultrasound data\n* Refuse follow-up"}, "identificationModule"=>{"nctId"=>"NCT06223906", "acronym"=>"BIOMS-HVD", "briefTitle"=>"A Registry Study of Biomarkers in Heart Valve Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"Beijing Institute of Heart, Lung and Blood Vessel Diseases"}, "officialTitle"=>"A Registry Study of Biomarkers in Heart Valve Disease", "orgStudyIdInfo"=>{"id"=>"BIOMS-HVD"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100029", "city"=>"Beijing", "state"=>"Beijing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Yuan Wang, PhD", "role"=>"CONTACT", "email"=>"wangyuan980510@163.com", "phone"=>"86-010-64456169"}, {"name"=>"Jie Du, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Beijing Anzhen Hospital", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}], "centralContacts"=>[{"name"=>"Yuan Wang, Dr", "role"=>"CONTACT", "email"=>"wangyuan980510@163.com", "phone"=>"13910161443"}, {"name"=>"Rui Lin, Dr", "role"=>"CONTACT", "email"=>"linrui2235@163.com", "phone"=>"15724230598"}], "overallOfficials"=>[{"name"=>"Jie Du, Dr", "role"=>"STUDY_DIRECTOR", "affiliation"=>"The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Beijing Institute of Heart, Lung and Blood Vessel Diseases", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
