[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07355894":3,"trial-entities:NCT07355894":130,"trial-summary:NCT07355894":134},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":73,"locations":76,"central_contacts":123,"overall_officials":124,"references":128,"see_also_links":129},"NCT07355894","84062","Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)","Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in AtheroSclerotic CardioVascular Disease (HEARTWISE-ASCVD) Study","NOT_YET_RECRUITING","2028-03","2026-01","2026-04-22","2026-05","Stanford University","OTHER",false,"This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled.\n\nIt will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are:\n\nDoes notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification?\n\nDoes the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing?\n\nHow does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)?\n\nResearchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.",null,[19,20],"Atherosclerotic Cardiovascular Disease (ASCVD)","Coronary Artery Calcification",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},120000,"ESTIMATED",[30],{"type":14,"name":31,"description":32,"armGroupLabels":33},"AI-Detected CAC Notification and Care Facilitation","After randomization to the early notification arm, the study team will send a standardized notification message to the participant's affiliated clinician. The study team will send a message to the participant after a brief delay. Each site will determine the timing between the initial message to the clinician and the participant based on stakeholder feedback.\n\nThe notification is about the AI-CAC identified on the participant's previous chest CT. It will provide an overview of AI-CAC, a personalized image of AI-CAC, and a recommended risk discussion with their clinician. These clinicians will also be notified of the findings.\n\nFor participants randomized to early notification who do not undergo LLT initiation, intensification, or LDL testing within 2 months, the clinician and participant will receive a second message at that time.\n\nThe participants in the delayed notification arm will receive a similar notification 6 months later.",[34],"Early Notification",[36],{"measure":37,"description":38,"timeFrame":39},"Lipid-lowering therapy initiation or intensification (LLTI)","* Number of new statin prescriptions\n* Number of statin doses\u002Fintensity increase\n* Number of PSCK9 inhibitor initiation (monoclonal antibodies and siRNA)\n* Number of Ezetimibe initiations\n* Number of Bempedoic acid initiations","6 months after participant randomization",[41,44,47,50,53],{"measure":42,"description":43,"timeFrame":39},"Aspirin prescription","Number of new Aspirin or other antiplatelet prescription",{"measure":45,"description":46,"timeFrame":39},"Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering","Number of Lipid panel ordering",{"measure":48,"description":49,"timeFrame":39},"Lipoprotein(a) test ordering","Number of Lipoprotein(a) test ordering",{"measure":51,"description":52,"timeFrame":39},"Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels","This outcome measure the changes of the test levels",{"measure":54,"description":55,"timeFrame":56},"Healthcare resource use","* Number of primary care clinical encounters\n* Number of cardiology encounters\n* Number of coronary artery disease-related imaging tests (e.g. noninvasive stress tests, coronary computed tomography angiography (CCTAs), and angiograms)","Baseline through Month 6","ALL","18 Years","74 Years",{"inclusion":61,"exclusion":66,"raw_text":72},[62,63,64,65],"Non-gated chest CT performed within the prior 2 years within the health system","Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following:","Meets one of the following clinical criteria:","Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg\u002FdL in the last 2 years, OR No LDL-C measurement in the last 2 years",[67,68,69,70,71],"Dementia","Heart transplant","Active hospice","Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)","Additional participant-level exclusions as determined by clinical stakeholders at each site","Inclusion Criteria:\n\n* Non-gated chest CT performed within the prior 2 years within the health system\n* Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following:\n\n  1. Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR\n  2. LDL-C measured within the health system within the prior 2 years, OR\n  3. Outpatient cardiovascular medication prescription within the prior year\n* Meets one of the following clinical criteria:\n\n  1. Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC \\>0 on non-gated chest CT, OR\n  2. No ASCVD diagnosis AND AI-detected CAC ≥100\n* Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg\u002FdL in the last 2 years, OR No LDL-C measurement in the last 2 years\n\nNote: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification.\n\nExclusion Criteria:\n\n* Dementia\n* Heart transplant\n* Active hospice\n* Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)\n* Additional participant-level exclusions as determined by clinical stakeholders at each site",[74,75],"ADULT","OLDER_ADULT",[77,86,93,99,107,115],{"facility":78,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"University of California, Los Angeles","Los Angeles","California","90095","United States",{"lat":84,"lon":85},34.05223,-118.24368,{"facility":87,"city":88,"state":80,"zip":89,"country":82,"geoPoint":90},"Kaiser Permanente Northern California","Pleasanton","94588",{"lat":91,"lon":92},37.66243,-121.87468,{"facility":13,"city":94,"state":80,"zip":95,"country":82,"geoPoint":96},"Stanford","94305",{"lat":97,"lon":98},37.42411,-122.16608,{"facility":100,"city":101,"state":102,"zip":103,"country":82,"geoPoint":104},"Duke University Medical Center","Durham","North Carolina","27710",{"lat":105,"lon":106},35.99403,-78.89862,{"facility":108,"city":109,"state":110,"zip":111,"country":82,"geoPoint":112},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"lat":113,"lon":114},36.16589,-86.78444,{"facility":116,"city":117,"state":118,"zip":119,"country":82,"geoPoint":120},"Baylor Scott & White","Dallas","Texas","95226",{"lat":121,"lon":122},32.78306,-96.80667,[],[125],{"name":126,"affiliation":13,"role":127},"Fatima Rodriguez, MD, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":131,"biomarkers":133},[132,20],"Atherosclerosis",[],{"nct_id":4,"found":135,"summary":136,"prompt_version":146},true,{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is an interventional study with a planned enrollment of 120,000 participants. Participants will be randomized, meaning they are assigned by chance, to receive either early notification or a delayed notification about their AI-detected CAC.","completed","HEARTWISE-ASCVD: AI-Detected CAC Notification for Cholesterol Treatment","This study, called HEARTWISE-ASCVD, is testing if using artificial intelligence (AI) to find calcium buildup in heart arteries (Coronary Artery Calcification or CAC) on existing chest CT scans can help improve cholesterol treatment. If the AI detects significant calcium, your doctor and you would receive a notification. The study aims to see if this leads to starting or increasing cholesterol-lowering medicines. You might be able to join if you are between 18 and 74 years old, have had a chest CT scan in the last two years, and have either known atherosclerotic cardiovascular disease (ASCVD) or significant calcium buildup with uncontrolled cholesterol. The study's main goal is to see if more people start or intensify their cholesterol-lowering therapy within 6 months.","The main outcome of the study, starting or intensifying cholesterol-lowering therapy, will be measured 6 months after you are randomized.",121,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]