CV-PREVITAL primary cardiovascular prevention trial: preliminary analysis assessing quality of data

CV-PREVITAL (ClinicalTrials.gov: NCT05339841) is a large-scale, prospective, randomized, controlled, open-label real-world interventional trial aimed at assessing the effectiveness of a digital intervention in primary cardiovascular prevention (BMJ Open. 2023; 13(7):e072040). The study follows a multi-cohort design, including general medicine, pharmacies, and IRCCS affiliated with the Italian Cardiology Network. In total, nearly 28,000 man and women (56%) aged ≥45 years were recruited. Despite standard operating procedures and quality control systems implemented to ensure data collection standardization, some differences can be expected due to variations in cohorts and data collection settings. To evaluate the potential impact of these differences on data quality, a preliminary analysis was conducted, also stratified by sex, aimed at assessing whether combining data from all cohorts into a single dataset provide reliable and meaningful information about established relationships between variables. Specifically, in the context of diabetes mellitus, we investigated the association between several variables associated to cardiometabolic risk (e.g. blood pressure, lipids, and overweight/obesity, or related therapies) and the presence of dysglicemia (including prediabetes and diabetes). The results of the preliminary analysis demonstrated high data quality. All the anticipated relationships between prediabetes/diabetes and variables associated with cardiometabolic risk were statistically significant, both within the entire study group and analysed separately by sex. These findings provide confidence in the overall quality of data collected throughout the study. On the basis of these results, the large sample size and the comprehensive collection of over 1000 variables, we are highly confident that the CV-PREVITAL study will hold significant potential not only for advancing knowledge in the field of digital medicine, but also for improving the current understanding of epidemiology of cardiovascular disease and diabetes in the Italian population. Funding: Italian Ministry of Health (RCR-2019-23669116_001). On behalf of the CV-PREVITAL STUDY GROUP.