[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05791227":3,"trial-entities:NCT05791227":96,"trial-summary:NCT05791227":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":60,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":80,"locations":83,"central_contacts":92,"overall_officials":93,"references":94,"see_also_links":95},"NCT05791227","STUDY00002521","Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)","EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness","ENROLLING_BY_INVITATION","2027-01-01","2026-07","2026-07-22","2025-04-01","Cedars-Sinai Medical Center","OTHER",false,"To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.",null,[19],"Heart Failure",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},4000,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","Sonographer Evaluation","A sonographer will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).",[34],"Sonographer Annotation",{"type":30,"name":36,"description":37,"armGroupLabels":38},"AI Evaluation","An AI model will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).",[39],"Artificial Intelligence Annotation",[41,45,48,51,54,57],{"measure":42,"description":43,"timeFrame":44},"Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd","Proportion of significant difference in LVIDd between preliminary to final assessment","10 Minutes",{"measure":46,"description":47,"timeFrame":44},"Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd","Proportion of significant difference in IVSd between preliminary to final assessment",{"measure":49,"description":50,"timeFrame":44},"Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd","Proportion of significant difference in LVPWd between preliminary to final assessment",{"measure":52,"description":53,"timeFrame":44},"mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms","Measurement difference of LVIDd between preliminary to final assessment",{"measure":55,"description":56,"timeFrame":44},"mean absolute error (MAE) of IVSd between preliminary to overread between the two arms","Measurement difference of IVSd between preliminary to final assessment",{"measure":58,"description":59,"timeFrame":44},"mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms","Measurement difference of LVPWd between preliminary to final assessment",[61,64,67],{"measure":62,"description":63,"timeFrame":44},"mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness","Mean absolute error (MAE) of wall thickness between cardiologist overread with initial interpretation vs. prior clinical report wall thickness",{"measure":65,"description":66,"timeFrame":44},"Time to complete each imaging study","Time for sonographers and cardiologists to complete a study (in seconds)",{"measure":68,"description":69,"timeFrame":44},"Effects of the AI systems integration with computer-human interaction (Blinding)","Whether cardiologists can tell the difference between human vs. AI initial interpretation (Bang's blinding index, or the proportion of studies guessed correctly to be AI or sonographer compared to ground truth of whether it was AI or sonographer).","ALL","18 Years","100 Years",{"inclusion":74,"exclusion":77,"raw_text":79},[75,76],"Sonographers and cardiologists at CSMC Echocardiography Lab","All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab",[78],"transthoracic echocardiogram studies not able to be measured by sonographers in run in period","Inclusion Criteria:\n\n* Sonographers and cardiologists at CSMC Echocardiography Lab\n* All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab\n\nExclusion Criteria:\n\n* transthoracic echocardiogram studies not able to be measured by sonographers in run in period",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":13,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Los Angeles","California","90048","United States",{"lat":90,"lon":91},34.05223,-118.24368,[],[],[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[19],[],{"nct_id":4,"found":100,"summary":101,"prompt_version":111},true,{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is a blinded, randomized controlled study comparing AI-guided measurements to sonographer measurements. It plans to enroll 4000 participants.","completed","AI Wall Thickness Measurement for Heart Failure (EchoNet-LVH-RCT)","This study is looking at how well an Artificial Intelligence (AI) tool can measure the thickness of heart walls compared to measurements made by sonographers (medical professionals who perform ultrasounds). The goal is to see if the AI tool can save time and make these measurements more accurate for people with heart failure. We're comparing AI Evaluation with Sonographer Evaluation to see if the differences in measurements for parts of the heart (left ventricular diameter, intraventricular septum thickness, and left ventricular posterior wall thickness) are small enough. This study is open to adults aged 18 to 100 years who are undergoing a specific type of heart ultrasound at the CSMC Echocardiography Lab. The study is currently unclear on its recruitment status and plans to include 4000 participants.","Measurements are taken at 10 minutes after the preliminary reading.",127,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]