← Eichor
Study identifier: NCT07695376 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

CARAMEL Observational Study

Condition: Perimenopause · Menopause · Cardiovascular (CV) Risk  ·  Sponsor: Biogipuzkoa Health Research Institute

PhaseN/A
Planned participants3000
Who can joinFemale, 40 Years to 60 Years
Healthy volunteersYes

About this study

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 o…

This description comes directly from the study's public registry record.

Talk to the study team

Primary Care - OSIs Research Unit  ·  (+34)943006086  ·  unidadinvestigaciongip@osakidetza.eus

Always discuss trial participation with your own doctor first.

Locations (6)

Keralty SASBogotá, ColombiaNot Yet Recruiting
Magdalena - Klinika Za Kardiovaskularne Bolesti Medicinskog Fakultetasveucilista J.J. Strossmayera U Osijeku UstanovaKrapinske Toplice, CroatiaNot Yet Recruiting
Ethniko Kai Kapodistriako Panepistimio AthinonAthens, GreeceRecruiting
Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros KlinikosVilnius, LithuaniaNot Yet Recruiting
Biogipuzkoa Health Research InstituteSan Sebastián, SpainRecruiting
Fundacion Para La Gestion de La Investigacion En Salud de SevillaSeville, SpainRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT07695376