Nctid:
NCT06611995
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D020521", "term"=>"Stroke"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"id"=>"D001281", "term"=>"Atrial Fibrillation"}], "ancestors"=>[{"id"=>"D002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D001145", "term"=>"Arrhythmias, Cardiac"}, {"id"=>"D006331", "term"=>"Heart Diseases"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M4586", "name"=>"Atrial Fibrillation", "asFound"=>"Atrial Fibrillation", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M4453", "name"=>"Arrhythmias, Cardiac", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1500}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-23", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Performance of a Deep Learning Framework for Predicting Ischemic Stroke Risk in AF Patients.", "timeFrame"=>"Through study completion, an average of 2 year.", "description"=>"This study aims to develop and evaluate a deep learning framework that automatically extracts Left Atrial Appendage (LAA) imaging features from 3D_slicer software and combines them with clinical characteristics to predict ischemic stroke risk in patients with atrial fibrillation (AF). The performance of the developed system will be evaluated using receiver operating characteristic (ROC) curves, area under the curve (AUC), accuracy, sensitivity, and specificity."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Atrial fibrillation", "Ischemic Stroke", "Deep Learning", "Chest CT", "Left Atrial Appendage"], "conditions"=>["Atrial Fibrillation (AF)", "Ischemic Stroke"]}, "descriptionModule"=>{"briefSummary"=>"This study aims to create and assess a deep learning framework for extracting left atrial appendage features in atrial fibrillation patients and combining them with clinical data to predict ischemic stroke risk. Clinical data and chest CT images from patients diagnosed with non-valvular atrial fibrillation will be collected. Patients will be categorized into stroke and non-stroke groups to build a data repository. The dataset will be divided into training and validation sets, with missing data handled and pulmonary vein CTV and virtual non-contrast images annotated. A deep learning model will be used for image segmentation and feature extraction to develop a prediction system.", "detailedDescription"=>"This study aims to develop and evaluate a deep learning framework that can automatically extract imaging features of the left atrial appendage in patients with atrial fibrillation and combine them with clinical features to predict the risk of ischemic stroke in these patients. The study intends to retrospectively collect clinical data (including patients\\' general information, medical history, laboratory tests, etc.) and chest CT images, as well as pulmonary vein CTV images (if available), from patients diagnosed with non-valvular atrial fibrillation between January 2018 and June 2024. The patients will be divided into stroke and non-stroke groups based on whether they have experienced an ischemic stroke, and a data analysis repository will be established. The dataset will be split into training and validation sets. Missing data will be handled, and data labeling will be performed on the pulmonary vein CTV sequence images and virtual non-contrast (VNC) sequence images. The left atrial morphology will be delineated, and a deep learning-based image segmentation network model will be developed to extract and select radiomic features for the prediction system."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who presented at various research center hospitals.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nDiagnosed with atrial fibrillation by ECG, 24-hour Holter monitor, or recordable ECG monitor; atrial fibrillation confirmed by an implanted pacemaker or defibrillator, lasting at least 30 seconds Available chest CT images and complete clinical data.\n\nExclusion Criteria:\n\nIncomplete clinical data or diagnosis of valvular atrial fibrillation (e.g., rheumatic heart valve disease, post-valve replacement) Poor-quality CT images that prevent complete assessment of left atrial appendage morphology Patients who have undergone left atrial appendage closure Patients who have had radiofrequency ablation or cardioversion with no evidence of recurrence post-procedure"}, "identificationModule"=>{"nctId"=>"NCT06611995", "briefTitle"=>"Prediction of Stroke Risk in Patients with Atrial Fibrillation Based on Chest CT Images", "organization"=>{"class"=>"OTHER", "fullName"=>"First Affiliated Hospital of Zhejiang University"}, "officialTitle"=>"Prediction of Stroke Risk in Patients with Atrial Fibrillation Based on Chest CT Images", "orgStudyIdInfo"=>{"id"=>"FAHZJU-Ethics-2024-NO.0990"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"People with atrial persistent fibrillation but without ischemic stroke", "interventionNames"=>["Other: observational study"]}, {"label"=>"People with atrial persistent fibrillation and ischemic stroke", "interventionNames"=>["Other: observational study"]}], "interventions"=>[{"name"=>"observational study", "type"=>"OTHER", "description"=>"Observational study without intervention", "armGroupLabels"=>["People with atrial persistent fibrillation and ischemic stroke", "People with atrial persistent fibrillation but without ischemic stroke"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"310003", "city"=>"Hangzhou", "state"=>"Zhejiang", "country"=>"China", "facility"=>"The First Affiliated Hospital, Zhejiang University School of Medicine", "geoPoint"=>{"lat"=>30.29365, "lon"=>120.16142}}], "centralContacts"=>[{"name"=>"Xiaosheng Hu", "role"=>"CONTACT", "email"=>"debora886@163.com", "phone"=>"+86 13588004492"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"First Affiliated Hospital of Zhejiang University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"The Fourth Affiliated Hospital of Zhejiang University School of Medicine", "class"=>"OTHER"}, {"name"=>"Taizhou Hospital", "class"=>"OTHER"}, {"name"=>"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University", "class"=>"OTHER"}, {"name"=>"Hangzhou Hospital of Traditional Chinese Medicine", "class"=>"OTHER"}, {"name"=>"Ningbo Medical Center Lihuili Hospital", "class"=>"OTHER_GOV"}, {"name"=>"Sanmen People Hospital", "class"=>"UNKNOWN"}, {"name"=>"Zhejiang Rongjun Hospital", "class"=>"OTHER_GOV"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Chief Physician", "investigatorFullName"=>"Hu Xiaosheng", "investigatorAffiliation"=>"First Affiliated Hospital of Zhejiang University"}}}}
