Status:
NOT_YET_RECRUITING
CARAMEL: Retrospective Study for Personalized Risk Assessment of Cardiovascular Disease in Menopausal and Perimenopausal Women Using Real World Data
Lead Sponsor:
Hospital Universitario Virgen Macarena
Collaborating Sponsors:
VISUAL INTERACTION & COMMUNICATION TECHNOLOGIES - VICOMTECH
Clinic for Cardiovascular Diseases Magdalena
Conditions:
Cardiovascular Risk Factors
Menopausal Women
Eligibility:
FEMALE
40-60 years
Brief Summary
This retrospective observational study, part of the EU-funded CARAMEL project, aims to develop and validate personalized cardiovascular disease (CVD) risk assessment models specifically designed for m...
Eligibility Criteria
Inclusion
- Self-identified as female in the electronic health record (EHR). Age between 40 and 60 years at the time of data collection/index date. Availability of at least 5-6 years of retrospective data in the EHR, depending on the research objective.
- At least one healthcare encounter (visit, imaging, lab test, diagnosis, etc.) within the defined age range.
- For imaging substudies (e.g., RO3-RO5): availability of at least one relevant imaging test (e.g., DXA, digital mammography, cMRI, CCTA, US) during the age range.
- For signal-based analysis (RO6): presence of ECG monitoring data from implanted devices and at least 2 years of follow-up.
Exclusion
- Prior diagnosis of cardiovascular disease before the observation window (only applicable to specific ROs, e.g., RO2, RO4).
- Insufficient data quality or missing key variables needed for modeling (e.g., absence of blood pressure or lipid profile).
- Patients with incomplete or inconsistent records (e.g., duplicate IDs, mismatched time frames).
- For signal-based RO6: hospitalizations or diagnoses unrelated to cardiovascular health that may bias AI model training.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1500000 Patients enrolled
Trial Details
Trial ID
NCT06999317
Start Date
July 1 2025
End Date
June 1 2026
Last Update
May 31 2025
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