Nctid:
NCT06221891
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000051436", "term"=>"Renal Insufficiency, Chronic"}, {"id"=>"D000018487", "term"=>"Ventricular Dysfunction, Left"}, {"id"=>"D000054160", "term"=>"Systolic Murmurs"}], "ancestors"=>[{"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000051437", "term"=>"Renal Insufficiency"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000006337", "term"=>"Heart Murmurs"}, {"id"=>"D000018754", "term"=>"Ventricular Dysfunction"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M10698", "name"=>"Kidney Diseases", "asFound"=>"Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M27583", "name"=>"Systolic Murmurs", "asFound"=>"Systolic", "relevance"=>"HIGH"}, {"id"=>"M26717", "name"=>"Renal Insufficiency, Chronic", "asFound"=>"Chronic Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M26718", "name"=>"Renal Insufficiency", "relevance"=>"LOW"}, {"id"=>"M20824", "name"=>"Ventricular Dysfunction", "relevance"=>"LOW"}, {"id"=>"M20591", "name"=>"Ventricular Dysfunction, Left", "asFound"=>"Left Ventricular Systolic Dysfunction", "relevance"=>"HIGH"}, {"id"=>"M9425", "name"=>"Heart Murmurs", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "asFound"=>"Chronic", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>500}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-10", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-11", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"first-phase ejection fraction", "timeFrame"=>"1 hour", "description"=>"an ultrasound indicator used to assess early left ventricular systolic function"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["first phase ejection fraction;left ventricular systolic dysfunction;echocardiography;chronic kidney disease"], "conditions"=>["Chronic Kidney Diseases", "Left Ventricular Systolic Dysfunction"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are:\n\n1. If first-phase ejection fraction（EF1）could early detect the left ventricular systolic dysfunction in patients with CKD.\n2. Whether EF1 can detect left ventricular systolic dysfunction in patients with CKD more sensitively than speckle-tracking echocardiography and myocardial work.\n\nParticipants will need to cooperate to do an echocardiography. Researchers will compare healthy volunteers and patients with CKD to see if EF1 could early detect the left ventricular systolic dysfunction."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.\n* LVEF≥50%.\n\nExclusion Criteria:\n\n* Patients with primary hypertension, diabetes and congenital heart disease.\n* Patients who are pregnant or lactating.\n* Patients with the blurry ultrasound images."}, "identificationModule"=>{"nctId"=>"NCT06221891", "briefTitle"=>"Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography", "organization"=>{"class"=>"OTHER", "fullName"=>"Fifth Affiliated Hospital, Sun Yat-Sen University"}, "officialTitle"=>"Early Evaluation of Left Ventricular Systolic Function Impairment in Patients With Chronic Kidney Disease by Multimodal Ultrasonography", "orgStudyIdInfo"=>{"id"=>"ZDWY.CSK.006"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"case group", "description"=>"This group contains the patients with chronic kidney disease."}, {"label"=>"control group", "description"=>"This group contains the healthy adults."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"519000", "city"=>"Zhuhai", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Qing Ye", "role"=>"CONTACT", "email"=>"2530774844@qq.com", "phone"=>"15625144037"}], "facility"=>"The Fifth Affiliated Hospital of Sun Yat-sen University", "geoPoint"=>{"lat"=>22.27694, "lon"=>113.56778}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fifth Affiliated Hospital, Sun Yat-Sen University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
