Personalized Cardiovascular Risk Assessment and Prevention for Women Aged 40 to 60 During Menopause Transition Using Artificial Intelligence

What this Trial Is About

Researchers are conducting the CARAMEL-OS observational study to develop and validate personalized artificial intelligence models for assessing cardiovascular risk in women aged 40 to 60 years during their menopausal transition. This project involves a collaboration of 25 organizations across Europe and Colombia, aiming to improve cardiovascular disease prevention by integrating multi-source data, including socioeconomic, clinical, biochemical, imaging, and novel non-invasive variables related to female-specific risk factors and menopause. The study will recruit a prospective cohort of 3,000 women from six clinical sites in four European countries and Colombia, with 500 participants contributed per site. Participants will be observed without any clinical intervention, using digital self-assessment and self-management tools, including a mobile app designed to support women during menopause. Data collected will help refine cardiovascular risk stratification models and develop new predictive tools with short-term horizons. Participants will be involved in assessments spanning 21 to 24 months depending on enrollment, during which incidence of hypertension, dyslipidaemia, diabetes mellitus, and cardiovascular disease will be recorded. Mortality related to cardiovascular events will also be tracked. The study focuses on gathering comprehensive data through questionnaires, imaging, biochemical tests, and digital monitoring to support personalized prevention strategies and advance precision medicine in womens cardiovascular health.

CARAMEL Observational Study