Prevention & lipids

Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomized controlled trial

Eur Heart J Qual Care Clin OutcomesPublished multicentre, open-label, randomized controlled study

Study context

Population
Adults aged 40–80 years without previous cardiovascular disease (CVD) or diabetes, recruited across Italyrecruited in Phase I, ≈12,000 eligible enter Phase II and are randomized · Phase II (randomized) 12,000
Participants
30,000 adults
Planned comparison
Imaging-based risk refinement, polygenic risk score (PRS), or their combination vs standard care
Primary endpoint
Co-primary: differences in estimated 10-year CVD risk at 12 months; incidence of major CVD events, CVD mortality, and all-cause mortality at 5 years
Follow-up
12 months; 5 years
Methodological detailsrationale and design
  • Rationale and design

No results yet. This paper sets out the design of a trial; its results are to come.

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomized controlled trial. Eur Heart J Qual Care Clin Outcomes. Published 4 March 2026. doi:10.1093/ehjqcco/qcag032

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