{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T18:09:38Z","timestamp":1786471778544,"version":"build-2736575974"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T00:00:00Z","timestamp":1772582400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Ricerca Corrente Reti","award":["RCR-2023-23684267"],"award-info":[{"award-number":["RCR-2023-23684267"]}]},{"DOI":"10.13039\/501100003196","name":"Italian Ministry of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100020676","name":"IRCCS Policlinico San Donato","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020676","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality worldwide. Current guidelines recommend algorithms to estimate 10-year CVD risk in apparently healthy individuals, but their precision remains limited. Whether the integration of imaging and genetic information can improve individual risk stratification remains uncertain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>The CVRISK-IT trial is a multicentre, open-label, randomized controlled study designed to enhance CVD prevention through precision-based risk assessment and targeted communication strategies. A total of 30 000 adults aged 40\u201380 years without previous CVD or diabetes are recruited across Italy. In Phase I, participants undergo a baseline assessment including clinical examination, blood sampling, and calculation of CVD risk. Approximately 12 000 eligible enter Phase II and are randomized equally into four intervention arms: (i) standard care (control), (ii) imaging-based risk refinement (coronary artery calcium score or carotid ultrasound), (iii) polygenic risk score (PRS), or (iv) combination of imaging and PRS. The co-primary endpoints are differences in estimated 10-year CVD risk at 12 months and the incidence of major CVD events, CVD mortality, and all-cause mortality at 5 years. Secondary endpoints include differences in CVD risk factors, prescription and adherence to preventive drug adherence, and behavioural or psychological measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>By prospectively evaluating the feasibility and impact of incorporating genetic and imaging information in CVD risk stratification, CVRISK-IT will generate robust evidence to inform its integration into routine screening practices and public health policy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov Identifier NCT06832644.<\/jats:p>\n                  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