Prevention & lipidsTrial design
Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomized controlled trial
- multicentre, open-label, randomized controlled study
- rationale and design
Study context
- Population
- Adults aged 40–80 years without previous cardiovascular disease (CVD) or diabetes, recruited across Italyrecruited in Phase I, approximately 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
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
Summarised from the published abstract; every number is checked against it