[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658722":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":39,"studyPopulation":11,"armGroups":40,"interventions":53,"overallOfficials":11,"centralContacts":59,"locations":68,"responsibleParty":85,"collaborators":87,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"HeartFlow, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT)",null,"Enrollment to 90 days",[14,17,19,21,23,25,27,29],{"measure":15,"description":11,"timeFrame":16},"Percentage of participants who initiate, intensify, cease, or de-escalate lipid-lowering therapy (LLT)","Enrollment through end of study at 21 months",{"measure":18,"description":11,"timeFrame":16},"Percentage of participants who initiate, intensify, cease, or de-escalate medication therapy",{"measure":20,"description":11,"timeFrame":16},"Time to initiation, intensification, cessation, or de-escalation of LLT",{"measure":22,"description":11,"timeFrame":16},"Percent of participants undergoing lipid testing",{"measure":24,"description":11,"timeFrame":16},"LDL-C changes",{"measure":26,"description":11,"timeFrame":16},"Changes in Plaque Volumes",{"measure":28,"description":11,"timeFrame":16},"Rates of referral to invasive coronary angiography and coronary revascularization",{"measure":30,"description":31,"timeFrame":16},"Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)","Evaluated using the 8-item MMAS-8 questionnaire. Total scores range from 0 to 8, where higher scores indicate better adherence. High adherence is defined as achieving a score of 8, medium adherence as 6 to \\\u003C8, and low adherence as \\\u003C6.",{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":11,"timePerspective":11,"maskingInfo":37},"RANDOMIZED","PARALLEL","Participants will be randomized using a 1:1 randomization scheme via an interactive web or voice-based system (IXRS). Randomization will occur into one of two arms: the test arm, in which participants will undergo CCTA blinded to coronary anatomy and receive unblinded Heartflow Analyses, or the usual care arm, in which participants will undergo a blinded CCTA with blinded Heartflow Analyses.","PREVENTION",{"masking":38,"maskingDescription":11,"whoMasked":11},"NONE","The primary objective of the REFINE-CAC trial is to assess change in lipid lowering therapy over time in asymptomatic participants with coronary artery calcium (CAC) findings who will undergo a blinded coronary computed tomographic angiography (CCTA) and are randomly assigned to either the test arm or the usual care arm.",[41,44,49],{"label":42,"type":43,"description":11,"interventionNames":11},"Usual Care Arm","NO_INTERVENTION",{"label":45,"type":46,"description":11,"interventionNames":47},"Unblinded Test Arm","EXPERIMENTAL",[48],"Device: Heartflow Analysis",{"label":50,"type":51,"description":11,"interventionNames":52},"Unblinded Registry Arm","OTHER",[48],[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"DEVICE","Heartflow Analysis","REFINE-CAC will provide Heartflow Analyses",[50,45],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Whitney Huey","CONTACT","8774783569","whuey@heartflow.com",{"name":66,"role":62,"phone":63,"phoneExt":11,"email":67},"Blair Holman","bholman@heartflow.com",[69],{"facility":70,"status":11,"city":71,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"REFINE-CAC Trial Site","New York","10005","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-74.00597,40.71427,{"lat":79,"lon":78},[82],{"name":83,"role":62,"phone":63,"phoneExt":11,"email":84},"Heartflow Investigator","refine-cac@heartflow.com",{"type":86,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[88],{"name":89,"class":6},"Avania","100658722","refine-cac-protocol-risk-evaluation-with-ai-cpa--hcs-for-patients-in-whom-calcium-is-confirmed-to-improve-coronary-artery-disease-care-100658722",false,"NCT07853716","REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care","Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care","REFINE-CAC","Inclusion Criteria:\n\n1. Calcium score between 1-299 between 3-6 months prior to Day 0 or incidental CAC findings on a chest CT between 3 to 6 months prior to Day 0\n2. Men ≥40 and ≤79, Women ≥45 and ≤79\n3. Patients who do not have symptoms suggestive of CAD\n4. Visible plaque on CCTA\n5. No other clinical CCTA subsequent to CAC findings but prior to screening\n6. No prior history of atherosclerotic cardiovascular disease (ASCVD)\n7. Acceptable CCTA quality per Heartflow acceptance criteria\n8. eGFR \\>45 mL\u002Fmin per most recent measurement within 90 days\n9. Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications\n10. For participants of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization\n11. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Symptoms suggestive of CAD (e.g. stable angina)\n2. On PCSK9 targeted therapy (e.g. evolocumab, alirocumab, inclisiran, or enlicitide)\n3. Reduced left ventricular ejection fraction (LVEF) \\\u003C35%, if known\n4. Prior history of ASCVD\n5. Prior coronary artery bypass graft (CABG)\n6. Prior percutaneous coronary intervention (PCI)\n7. Life expectancy less than 2 years due to non-CV comorbidities\n8. Enrolled in an investigational trial that involves a non-approved cardiac drug or device\n9. Previously evaluated with and\u002For in a trial which includes AI-CPA\n10. Any condition that might interfere with trial procedures or follow up visits\n11. LDL-C \\\u003C70 mg\u002FdL at baseline lab draw\n12. Active chemotherapy and\u002For radiation","ALL","40 Years","79 Years",{"count":102,"type":103},500,"ESTIMATED","INTERVENTIONAL",[106],"NA","REFINE-CAC is a prospective, multi-center trial assessing the management of asymptomatic participants with CAC scores 1-299 Agatston units or incidental CAC findings on chest computed tomography (CT), all of whom will undergo CCTA and are blinded to the coronary anatomy (e.g., % stenosis). The trial includes a randomized, controlled pathway and a single arm, observational registry pathway.",[109],"CAD - Coronary Artery Disease",[111,112,113,114,115,116,117],"CAD","AI-CPA","CCTA","CACS","CAC","Coronary Plaque","Incidental CAC","NOT_YET_RECRUITING","2026-09-28",{"date":121,"type":122},"2026-10-02","ACTUAL",{"date":124,"type":103},"2026-11",{"date":126,"type":103},"2029-06",{"name":5,"class":6},1]