Abstract Background Cardiovascular diseases (CVD) represent a major global health concern, requiring innovative primary prevention strategies. Personalized prevention, through the use of digital technologies and genetic risk scores (PRS), holds promise but requires further investigation to assess clinical efficacy. Consequently, the INNOPREV trial aims to investigate the efficacy of PRS and/or digital technologies in the uptake of CV preventive behaviors uptakes. Methods The INNOPREV trial is a multicenter randomized controlled trial conducted in Italy across three hospital centers in Rome, Catania, and Palermo. It aims to recruit 1020 participants aged 40-69 with a high 10-year CVD risk. Participants are allocated to traditional CVD risk assessment, or genetic testing, or digital interventions, or a combination of both. The study involves comprehensive CV risk assessments at baseline and follow-up visits at one, five, and twelve months. Data analysis will utilize mixed-effects models to analyze longitudinally collected data and explore potential moderators and mediators of behavior change. Results Preliminary results indicate good progress in recruitment, which currently stands at 250 participants (25% of expected). Recruited females have a mean age of 59 ± 6 years, while males have a mean age of 58 ± 6 years. Currently, PRS analyses indicate that 77% of participants have intermediate scores, and 23% have low scores. Follow-up will be essential to evaluate the efficacy of the proposed interventions. Conclusions We expect that the INNOPREV trial will provide evidence towards integration of innovative approaches based on PRS and digital devices, in the traditional preventive approaches for CVDs. Expectations are high based on the limited effectiveness of the current approaches in CV risk reduction based on lifestyle advice. Key messages • INNOPREV trial examines PRS and digital technology for CVD prevention, aiming to enhance preventive efficacy. Initial findings suggest promising potential for innovative CVD prevention strategies. • The INNOPREV trial aims to investigate the efficacy of personalized prevention strategies, including PRS and digital technologies, in improving cardiovascular preventive behaviors.
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