nctId: NCT06280976 id: 23.0001 briefTitle: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) acronym: ARTCAP overallStatus: RECRUITING date: 2024-03-01 date: 2029-01-31 date: 2029-01-31 date: 2024-02-28 date: 2024-04-25 name: University of Louisville class: OTHER briefSummary: The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat. conditions: Coronary Artery Disease conditions: Atherosclerosis conditions: Heart Attack studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PROBE design: Prospective Randomized Open Label Blinded End-point primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Statin name: Aspirin tablet name: Nexlizet name: LEQVIO name: Vascepa name: Jardiance name: Colchicine measure: Plaque quantification measure: Characterization of plaque to evaluate for high-risk features - positive remodeling measure: Quantification of stenosis measure: Quantification of pericoronary fat attenuation. measure: Characterization of plaque to evaluate for high-risk features - low CT attenuation measure: Characterization of plaque to evaluate for high-risk features - napkin-ring sign measure: Quantification of epicardial fat attenuation. measure: Major adverse cardiac and cardiovascular events (MACCE) measure: Polygenic risk score (PRS) measure: Next generation sequencing (NGS) measure: Change in Lipoprotein (a) measure: Change in myeloperoxidase (MPO) activity measure: Change in trimethylamine-N-oxide (TMAO) levels measure: Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels measure: Change in interleukin-6 (IL-6) levels measure: Change in high sensitivity C-creative protein (HS-CRP) levels measure: Buffy coat for chromatin immunoprecipitation (ChIP) measure: Change in high sensitivity Troponin (HS-Tn) measure: Change in natriuretic peptide (BNP, NT-pro BNP measure: Change in levels of open reading frame 1 protein (ORF1p) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases status: RECRUITING city: Louisville state: Kentucky zip: 40202 country: United States name: Dinesh Kalra, MD role: CONTACT phone: 502-588-7010 email: diniesh.kalra@louisville.edu name: Muhammad Umer, MD role: CONTACT phone: 502-588-7010 email: muhammad.umer.1@louisville.edu lat: 38.25424 lon: -85.75941 hasResults: False