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Thereby, the control group does not undergo neither imaging nor genetic analysis.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Imaging","EXPERIMENTAL","Subjects randomized in the imaging arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on imaging data analysis (i.e., carotid ultrasound or calcium score)",[18],"Behavioral: Lifestyle Management",{"label":20,"type":15,"description":21,"interventionNames":22},"Polygenic Risk Score (PRS)","Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on polygenic risk score (PRS) analysis obtained from blood samples collected at the baseline visit",[18],{"label":24,"type":15,"description":25,"interventionNames":26},"Imaging and Polygenic Risk Score (PRS)","Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on both imaging data (e.g., carotid ultrasound and\u002For calcium score) and genetic analysis (e.g., PRS).",[18],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":12},"BEHAVIORAL","Lifestyle Management","All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I.",[14,24,20],[34,52,64,76,86,95,104,114,124,134,146,158,170,179,191,203,212],{"facility":35,"status":36,"city":37,"state":37,"zip":12,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"IRCCS Cardiologico Monzino","RECRUITING","Milan","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],9.18951,45.46427,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":12,"email":51},"Damiano Baldassarre, MD","CONTACT","+39 02.58002369","damiano.baldassarre@cardiologicomonzino.it",{"facility":53,"status":54,"city":55,"state":12,"zip":12,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Irccs 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Clinici Scientifici Maugeri SpA",{"name":246,"class":6},"Istituto Di Ricerche Farmacologiche Mario Negri",{"name":115,"class":6},{"name":249,"class":6},"Istituto Neurologico Mediterraneo Neuromed S. R. L",{"name":251,"class":6},"IRCCS San Raffaele",{"name":204,"class":6},{"name":254,"class":6},"IRCCS SYNLAB SDN",{"name":256,"class":6},"Istituto Clinico Humanitas",{"name":258,"class":6},"Istituto Nazionale di Ricovero e Cura per Anziani",{"name":260,"class":6},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies",{"name":262,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"name":264,"class":6},"Ospedale Policlinico San Martino",{"name":266,"class":6},"Istituto Auxologico Italiano","100580080","novel-risk-prediction-approaches-for-the-primary-prevention-of-cardiovascular-diseases-in-italy-the-cvrisk-it-trial-cvrisk-it-100580080",false,"NCT06832644","Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)","Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial","CVRISK-IT","Inclusion Criteria:\n\n* Age: 40-80 years\n* Apparently healthy individuals without previous medical history of CVD or diabetes (based on medical diagnosis)\n* Participant recruitment arranged only at selected IRCCS (and associated Spokes) as part of the 'Rete Cardiologica'\n* Participants must have signed the Informed Consent and Data Privacy Treatment forms\n* Participants must have a personal e-mail address and internet connection\n\nExclusion Criteria:\n\n* Age ≤40 or ≥80 years\n* Individuals have previous medical history related to CVD (e.g., heart failure, congenital heart disorder, coronary heart disease) based on medical diagnosis\n* Candidates have previously participated in clinical studies of 'Rete Cardiologica' (e.g., PREVITAL)\n* Medical diagnosis of mental disorders\n* Pregnancy based on self-reported information\n* Previous history of type 1 or type 2 diabetes (based on medical diagnosis)\n* Oncology patients (based on physician indication)",true,"ALL","40 Years","80 Years",{"count":280,"type":281},30000,"ESTIMATED","INTERVENTIONAL",[284],"NA","The CVRISK-IT study aims to evaluate the health benefit of measuring genetic and imaging risk information in men and women considered at 'low-to-moderate' or 'high' risk of developing cardiovascular diseases (CVD) in a randomized controlled trial in Italian primary care settings. Our primary objective is to answer a fundamental question in the prevention and prediction of CVD in Italy and globally: is there any benefit in including additional information (such as genetic and\u002For imaging data) in estimating risk, in conjunction with lifestyle advice and medical treatment for primary prevention of CVD?\n\nAs a key secondary objective of the CVRISK-IT study, the goal is to build a large bioresource with clinical information and biological samples to facilitate a new generation of discovery and translational research that will advance understanding of the genetic, molecular and behavioural determinants as well as mechanisms of multiple chronic diseases in the Italian population. By contributing to the Rete Cardiologica database and the BBDCARDIO biobank, the CVRISK-IT study will also serve as a cornerstone for future investigations into the development and testing of early diagnostic technologies and preventive (or 'personalised precision health') interventions for chronic diseases.",[287,288],"Cardiovascular Risk","Genetic Cardiovascular Risk",[290,287,291],"Primary Prevention","SCORE2\u002F2-OP","2026-01-12",{"date":294,"type":295},"2026-01-14","ACTUAL",{"date":297,"type":295},"2025-01-22",{"date":299,"type":281},"2030-01-01",{"name":5,"class":6},17]