CARAMEL Observational Study

Recruiting now

Conditions studied: Perimenopause, Menopause, Cardiovascular (CV) Risk, Women (Between 30 to 60 Years Old), Cardiovascular Disease Risk Factor, Artificial Intelligence (Al)

In brief

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.

Key facts

Study ID: NCT07695376
Run by: Biogipuzkoa Health Research Institute
People needed: 3000
Starts: 2026-03-16
Expected to finish: 2028-11-01
Last updated by the study team: 2026-07-10

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Women 40 to 60 years of age, at recruitment.
Ability to understand and complete the required informed consent for the study.
Women who are covered by the corresponding healthcare system operating at each clinical site.

You may not qualify if…

Severe comorbidity with less than 24 months life expectancy.
Lack of basic digital skills to use or carry a smartphone and wearable devices.

Where it is running

Ethniko Kai Kapodistriako Panepistimio Athinon — Athens, Greece (enrolling)
Biogipuzkoa Health Research Institute — San Sebastián, Spain (enrolling)
Fundacion Para La Gestion de La Investigacion En Salud de Sevilla — Seville, Spain (enrolling)
Keralty SAS — Bogotá, Colombia
Magdalena - Klinika Za Kardiovaskularne Bolesti Medicinskog Fakultetasveucilista J.J. Strossmayera U Osijeku Ustanova — Krapinske Toplice, Croatia
Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos — Vilnius, Lithuania

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.