CARAMEL: Personalizing Heart Risk in Women 40–60

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CARAMEL-OS is an observational project designed to refine a women-focused cardiovascular risk model developed under the Horizon Europe CARAMEL program. It collects socioeconomic, clinical, biochemical, imaging, and novel non-invasive data from about 3,000 women across six sites to improve prediction of cardiovascular risk during the menopausal transition. The study emphasizes multi-source data integration and aims to support decision-making with a mobile datApp that acts as a personalized companion for menopause-related cardiovascular health. It does not involve interventional treatments, but seeks to advance precision prevention strategies for women’s cardiovascular health. The consortium includes 25 organizations spanning clinical centers, technology partners, and ethics and communication experts to ensure comprehensive methodological rigor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Ethniko Kai Kapodistriako Panepistimio Athinon
  Athens, Greece Recruiting
• Biogipuzkoa Health Research Institute
  San Sebastián, Spain Recruiting
• Fundacion Para La Gestion de La Investigacion En Salud de Sevilla
  Seville, Spain Recruiting
• Keralty SAS
  Bogotá, Colombia Not yet recruiting
• Magdalena - Klinika Za Kardiovaskularne Bolesti Medicinskog Fakultetasveucilista J.J. Strossmayera U Osijeku Ustanova
  Krapinske Toplice, Croatia Not yet recruiting
• Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos
  Vilnius, Lithuania Not yet recruiting

Study contacts

• Study coordinator: Primary Care - OSIs Research Unit
• Email: unidadinvestigaciongip@osakidetza.eus
• Phone: (+34)943006086

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.