CARAMEL Observational Study

Sponsor
Biogipuzkoa Health Research Institute
Study ID
NCT07695376
Status
Recruiting
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Conditions

  • Artificial Intelligence (Al)
  • Cardiovascular (CV) Risk
  • Cardiovascular Disease Risk Factor
  • Menopause
  • Perimenopause
  • Women (Between 30 to 60 Years Old)

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Accepted

Study Details

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 Dates

First listed
Jul 10, 2026
Start date
Mar 16, 2026
Status verified
Jul 2026
Primary completion
May 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: 3,000 women aged 40-60 recruited in four European Union countries and Colombia.
    The study population will be recruited in five sites belonging to four European Union countries: Croatia, Spain (Andalusia and The Basque Country - Gipuzkoa), Greece and Lithuania; and one South America country that is Colombia. A prospective cohort of 3,000 women aged 40-60 will be recruited, with each partner contributing 500 participants.

Primary Outcome Measure

Incidence of hypertension [ Time Frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date. ]

Central Contacts

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