CARAMEL Observational 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.

Conditions

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

Sponsors & Collaborators

• Fundación Centro de Tecnologías de Interacción Visual y Comunicaciones Vicomtech

  collaborator UNKNOWN

• Keralty SAS

  collaborator UNKNOWN

• Particle Summary

  collaborator UNKNOWN

• iBreve Limited

  collaborator UNKNOWN

• Magdalena Clinic

  collaborator UNKNOWN

• Andaluz Health Service

  collaborator OTHER_GOV

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  collaborator OTHER

• Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos

  collaborator UNKNOWN

• Asociación Centro de Investigación Cooperativa en Biociencias

  collaborator UNKNOWN

• Ulma Medical Technologies S Coop

  collaborator UNKNOWN

• Smartnanosenose Innovation

  collaborator UNKNOWN

• ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

  collaborator UNKNOWN

• Biogipuzkoa Health Research Institute

  lead OTHER

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-16

Primary Completion

2028-05-31

Completion

2028-11-30

Countries

• Colombia
• Croatia
• Greece
• Lithuania
• Spain

Study Locations