Condition: Perimenopause · Menopause · Cardiovascular (CV) Risk · Sponsor: Biogipuzkoa Health Research Institute
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.
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| 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 |
| Ethniko Kai Kapodistriako Panepistimio Athinon | Athens, Greece | Recruiting |
| Viesoji Istaiga Vilniaus Universiteto Ligonine Santaros Klinikos | Vilnius, Lithuania | Not Yet Recruiting |
| Biogipuzkoa Health Research Institute | San Sebastián, Spain | Recruiting |
| Fundacion Para La Gestion de La Investigacion En Salud de Sevilla | Seville, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07695376