Nctid:
NCT06234241
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>2000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-06-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-12-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-10-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Cardiac volumes", "timeFrame"=>"2024-10-31", "description"=>"Including the left and right atria and left and right ventricles"}, {"measure"=>"Cardiac Function", "timeFrame"=>"2024-10-31", "description"=>"Including the left and right atria and left and right ventricles"}, {"measure"=>"Cardiac strain", "timeFrame"=>"2024-10-31", "description"=>"Including the left and right atria and left and right ventricles"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Heart Chambers"]}, "descriptionModule"=>{"briefSummary"=>"Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence.", "detailedDescription"=>"We will establish normal reference values for the volume, function and strain of various heart chambers of Chinese people based on the recruitment of healthy Chinese subjects."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Chinese Han healthy adults", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age ≥ 18 years; No history or clinical evidence of cardiac, cardiovascular, lung, or kidney disease; No abnormal findings on physical examination, biochemical examination, electrocardiography, or echocardiography.\n\nExclusion Criteria:\n\n* Hypertension (blood pressure \\[BP\\] \\> 140/80 mmHg) or receiving medication for hypertension; body mass index \\> 30 kg/m2; total cholesterol ≥ 6.2 mmol/L, triglyceride ≥ 2.3 mmol/L, or high-density lipoprotein cholesterol \\< 1.0 mmol/L; endocrine diseases, such as diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L), thyroid disease, pheochromocytoma, adrenal insufficiency, and hyperaldosteronism; anemia; abnormal liver function; connective tissue diseases, such as rheumatoid arthritis, vasculitis, systemic lupus erythematosus, dermatomyositis, and scleroderma; malignancy; current pregnancy or lactation; professional sport activity; and a history of alcoholism."}, "identificationModule"=>{"nctId"=>"NCT06234241", "briefTitle"=>"Normal Values of Cardiac Measurements by Echocardiography in Chinese Based on Artificial Intelligence", "organization"=>{"class"=>"OTHER", "fullName"=>"First Hospital of China Medical University"}, "officialTitle"=>"Normal Reference Values of Cardiac Measurements by Echocardiography in Chinese Han Adults Based on Artificial Intelligence: A Multi-center Study in China", "orgStudyIdInfo"=>{"id"=>"2023-445"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Echocardiography", "type"=>"OTHER", "description"=>"Echocardiography was performed in all enrolled populations."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"110001", "city"=>"Shenyang", "state"=>"Liaoning", "country"=>"China", "facility"=>"The First Hospital of China Medical University", "geoPoint"=>{"lat"=>41.79222, "lon"=>123.43278}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tianxin Dong", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"MD", "investigatorFullName"=>"Tianxin Dong", "investigatorAffiliation"=>"First Hospital of China Medical University"}}}}
