CARAMEL Observational Study

Condition(s) studied

Study summary

CARAMEL is a project funded by the European Commission under the Horizon Europe programme. Its aim is to develop a personalized prevention approach based on state-of-the-art artificial intelligence models for cardiovascular risk stratification in women aged 40-60 years. These models are trained using large amounts of multi-source data and complemented by digital self-assessment and self-management tools. The CARAMEL consortium brings together a diverse group of 25 organizations, including technology companies and research centers, clinical institutions, as well as experts in ethics, law, and communication.

The CARAMEL-OS study is an observational study aimed at prospectively completing the proposed personalized cardiovascular risk stratification model for women aged 40-60 years that will be developed during the earlier phases of the overall CARAMEL project (https://www.caramel-project.eu/).

The study has a purely observational design, and patient stratification will not entail any clinical intervention. The data collected will be used to complete the design of the personalized stratification model, as well as to develop and validate the performance of the predictive models in an independent prospective cohort, distinct from the retrospective cohort initially used. The performance of the models developed using retrospective data will be assessed in terms of accuracy, discrimination, calibration, and other relevant metrics. In addition, the study will enable the development of new predictive models with short-term prediction horizons, incorporating additional variables that are not available retrospectively.

The study population will be recruited in four European Union countries: Croatia, Spain (Andalusia and The Basque Country - Gipuzkoa), Greece and Lithuania; and in Colombia. A prospective cohort of 3,000 women aged 40-60 will be recruited, with each partner contributing 500 participants.

Eligibility

Primary outcome measure(s)

• Incidence of hypertension — From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
  Incidence of hypertension will be assessed by measuring blood pressure during the baseline and final study visits, as well as by reviewing the diagnosis of hypertension recorded in the electronic health records. Participants enrolled during a self-monitoring month will be asked to measure their blood pressure twice daily throughout 1 month.
• Incidence of dyslipidaemia — From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
  Incidence of dyslipidaemia will be assessed through blood tests measuring HDL cholesterol, LDL cholesterol, total cholesterol, and triglyceride levels at the baseline and final study visits, as well as by reviewing diagnoses of dyslipidaemia recorded in the electronic health records.
• Incidence of diabetes mellitus — From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
  Incidence of diabetes mellitus will be assessed through blood tests measuring glomerular filtration rate, albumin-to-creatinine ratio, glucose and glycated hemoglobin levels at the baseline and final study visits, as well as by reviewing diagnoses of diabetes mellitus recorded in the electronic health records.
• Incidence of cardiovascular disease — From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
  The incidence of cardiovascular disease will be assessed through the diagnosis of the following conditions: myocardial infarction, chronic coronary syndrome, peripheral arterial disease, and stroke. This information will be collected through a structured medical history interview and by reviewing the electronic health records. These data will be collected during the baseline visit and the final visit.

Trial sites (6)

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