CARAMEL Observational Study (CARAMEL-OS)

July 6, 2026 updated by: Biogipuzkoa Health Research Institute

CArdiovascular Risk Assessment Via Multimodal Data Analysis Enabling Personalised Prevention Strategies Targeting MEnopausaL Women - Observational 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 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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

A prospective observational study involving 3,000 women across six clinical sites will be conducted to generate a comprehensive multi-source dataset for the development of cardiovascular disease (CVD) risk assessment models. In addition to socioeconomic, clinical, biochemical, and imaging data, the study will use novel non-invasive technologies to collect additional potentially relevant variables, aiming to improve understanding of female-specific cardiovascular risk factors and biological changes around menopause age. By refining the CARAMEL stratification scheme based on the most effective approaches, the project aims to provide innovative tools for personalized CVD prevention and risk stratification. This ambitious and integrative approach is expected to advance precision medicine in women's cardiovascular health, support clinical decision-making, and inform future preventive strategies at both individual and population levels. Central to these strategies is the development of the datApp - a mobile application designed to serve as a personalised companion for women throughout their menopausal transition.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Not yet recruiting
        • Keralty SAS
        • Contact:
  • Croatia
      • Krapinske Toplice, Croatia
        • Not yet recruiting
        • Magdalena - Klinika Za Kardiovaskularne Bolesti Medicinskog Fakultetasveucilista J.J. Strossmayera U Osijeku Ustanova
        • Contact:
  • Greece
      • Athens, Greece
        • Recruiting
        • Ethniko Kai Kapodistriako Panepistimio Athinon
        • Contact:
  • Lithuania
      • Vilnius, Lithuania
        • Not yet recruiting
        • Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos
        • Contact:
  • Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Eligible women may be invited to participate by their regular healthcare provider or may express their interest independently. To maximize representativeness, information about the study will be disseminated via multiple communication channels, including social media platforms (e.g., LinkedIn, Facebook, Bluesky, X). Women who express interest will be contacted by the CARAMEL research team, and detailed study documentation will be provided.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hypertension
Time Frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Incidence of hypertension will be assessed by measuring blood pressure during the baseline and final study visits, as well as by reviewing the diagnosis of hypertension recorded in the electronic health records. Participants enrolled during a self-monitoring month will be asked to measure their blood pressure twice daily throughout 1 month.
From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Incidence of dyslipidaemia
Time Frame: From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of dyslipidaemia will be assessed through blood tests measuring HDL cholesterol, LDL cholesterol, total cholesterol, and triglyceride levels at the baseline and final study visits, as well as by reviewing diagnoses of dyslipidaemia recorded in the electronic health records.
From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of diabetes mellitus
Time Frame: From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of diabetes mellitus will be assessed through blood tests measuring glomerular filtration rate, albumin-to-creatinine ratio, glucose and glycated hemoglobin levels at the baseline and final study visits, as well as by reviewing diagnoses of diabetes mellitus recorded in the electronic health records.
From enrollment to program completion, lasting 21-24 months depending on the enrollment date.
Incidence of cardiovascular disease
Time Frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
The incidence of cardiovascular disease will be assessed through the diagnosis of the following conditions: myocardial infarction, chronic coronary syndrome, peripheral arterial disease, and stroke. This information will be collected through a structured medical history interview and by reviewing the electronic health records. These data will be collected during the baseline visit and the final visit.
From enrollment to program completion, spanning 21-24 months depending on the enrollment date.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality of cardiovascular events.
Time Frame: From enrollment to program completion, spanning 21-24 months depending on the enrollment date.
Mortality of cardiovascular events will be assessed through review of electronic health records, collecting information on new cardiovascular events and mortality occurring during the follow-up period and identified at the final assessment.
From enrollment to program completion, spanning 21-24 months depending on the enrollment date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogipuzkoa Health Research Institute

Collaborators

Andaluz Health Service
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Fundación Centro de Tecnologías de Interacción Visual y Comunicaciones Vicomtech
Keralty SAS
Particle Summary
iBreve Limited
Magdalena Clinic
AE. Fundación Pública Andaluza para la gestión de la investigación en salud de Sevilla
Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos
Asociación Centro de Investigación Cooperativa en Biociencias
Ulma Medical Technologies S Coop
Smartnanosenose Innovation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2025166 (PS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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