CardioGAP+: bridging the gap between patient identification and therapy implementation in cardiovascular risk

In the face of escalating medical complexity, the development of simple strategies that allow the optimization of resources becomes more urgent than ever. This is particularly evident in cardiovascular diseases (CVD), where despite successful risk stratification and mitigation strategies, elevated mortality rates persist among socioeconomically disadvantaged groups. Efforts to prevent CVD events rely on early identification of at-risk individuals and timely implementation of risk-mitigating measures. Persistent challenges in health systems to identify and intervene with high-risk patients underline the growing importance of implementation science. Operating in the real-world context, this field allows to bridge the gap between identifying at-risk individuals and implementing tailored therapeutic strategies, facilitating the clinical assimilation of diagnostic and therapeutic advancements. RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework was applied to structure and evaluate this implementation process.

The CARDIOGAP + project emerges as a prospective solution to this challenge. By focusing on the industrial and manufacturing workforce, it seeks to achieve the early identification of high and very high-risk individuals through data routinely collected in Occupational Medicine (OM) appointments, which occur biennially (or annually for individuals aged 50 or over). Patients will be risk stratified according to the ESC guidelines using the data collected on the OM appointments, allowing a systematic and prompt recognition of individuals at elevated cardiovascular (CV) risk. The identified patients will be referred to a CV risk hospital consultation, where therapeutic interventions fostering adherence will be implemented. After the first hospital appointment, patients will be followed up to 1 year. As a pilot implementation study, sample size was determined by feasibility and precision considerations rather than by a formal power calculation for the exploratory 12-month risk-factor outcomes.

This study was developed with reference to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations, adapted for a non-randomized implementation study, and in compliance with the Declaration of Helsinki and Good Pharmacoepidemiology Practice (GPP). Reporting of study results will follow the STROBE guidelines, ensuring ethical conduct and data integrity. Written informed consent will be obtained from all participants or their legal representatives. Confidentiality is safeguarded through de-identification and secure data storage. Results may be published or shared in public databases, following Novartis and ICMJE standards.