[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06808334":3,"trial-entities:NCT06808334":86,"trial-summary:NCT06808334":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":53,"locations":56,"central_contacts":74,"overall_officials":79,"references":84,"see_also_links":85},"NCT06808334","CPS-En01","CLAiR Pivotal Study","RECRUITING","2025-10-01","2025-03","2025-03-25","2025-02-27","Toku Eyes Ltd","INDUSTRY",false,"This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.","This is a prospective observational clinical study to collect retinal images and clinical biomarker data in order to analyze the performance of the CLAiR SaMD compared to the reference PCE risk score. CLAiR is a deep learning (DL) model that uses retinal photographs and limited demographic data to classify an individual's risk of developing ASCVD over the next 10 years as elevated (≥7.5%) or non-elevated (\\\u003C7.5%). For validation, the output of the algorithm can be directly compared to the PCE output, a widely accepted algorithm used by Healthcare Providers to predict ASCVD risk in patients.\n\nThe primary hypothesis is that the CLAiR SaMD can achieve high sensitivity and specificity in the binary determination of Yes\u002FNo elevated ASCVD risk with PCE risk score ≥7.5% as the reference standard.",[18],"No Condition",[20,21,22,23,24],"retinal image","ASCVD","AI","cardiovascular risk","adults","OBSERVATIONAL",null,[],{"count":29,"type":30},942,"ESTIMATED",[32],{"type":33,"name":34,"description":35},"OTHER","CLAIR","Subject will have retinal images obtained and uploaded to CLAiR Software. Subjects are not directly in contact with CLAiR software. There is no medical intervention.",[37],{"measure":38,"description":39,"timeFrame":40},"Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.","Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y\u002FN) against the reference standard of PCE ≥ 7.5%","through study completion, an average of 6 months",[],"ALL","40 Years","75 Years",true,{"inclusion":47,"exclusion":48,"raw_text":52},[],[49,50,51],"Persistent vision impairment: legally blind when wearing current driving glasses or known VA\\\u003C20\u002F400","Known pathological myopia","Previous treatment or currently under the care for a retinal disease by a specialist (e.g., ophthalmologist)","Inclusion Criteria:\n\n1. Male or female, aged 40-75 years\n2. Participants must be capable of providing informed consent, demonstrating understanding of the study details, and willingly sign a consent form or verbally confirm their consent in the presence of a witness.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting\n2. Current use of cholesterol-lowering medication, such as a statin\n3. Pregnancy\n4. A person who has (in at least one eye):\n\n   * Persistent vision impairment: legally blind when wearing current driving glasses or known VA\\\u003C20\u002F400\n   * Known pathological myopia\n   * Previous treatment or currently under the care for a retinal disease by a specialist (e.g., ophthalmologist)",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":71},"Diabetes and Endocrine Associates of Stark County","Canton","Ohio","44718","United States",[64,68],{"name":65,"role":66,"email":67},"Brandi Kerr","CONTACT","brandik@go2endo.com",{"name":69,"role":70},"Arvind Krishna, MD","PRINCIPAL_INVESTIGATOR",{"lat":72,"lon":73},40.79895,-81.37845,[75],{"name":76,"role":66,"phone":77,"email":78},"Yariv Levinson","(240) 442 2479","yariv.levin@tokueyes.com",[80],{"name":81,"affiliation":82,"role":83},"Michael McConnell, MD","Toku Inc.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Atherosclerosis",[],{"nct_id":4,"found":45,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study involving 942 participants. It is designed to compare the CLAiR software's performance against a standard risk score.","completed","CLAiR Pivotal Study for ASCVD Risk Identification","This study is looking at how well a special artificial intelligence (AI) software called CLAiR can identify your risk of developing atherosclerotic cardiovascular disease (ASCVD), which is a type of heart disease. CLAiR uses images of your retina (the back of your eye) to do this. You would have retinal images taken, which are then analyzed by the CLAiR software. There are no medical interventions involved. This study aims to see if CLAiR can accurately tell if you have an elevated ASCVD risk, compared to a standard risk score used by doctors. People aged 40 to 75 can join, as long as they can understand and agree to the study procedures. The study is considered successful if CLAiR can accurately identify elevated ASCVD risk. The current recruitment status is unclear.","The primary endpoint is measured through study completion, which averages 6 months.",130,"You would need to provide informed consent and have retinal images obtained. You would also need to be available for the duration of the study, which averages 6 months.","Not stated in the trial record.",[34],"v2"]