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AI-THEROSCOPE: AI Detection of Subclinical Atherosclerosis From Retinal Images
Sponsor: Infanta Leonor University Hospital
Summary
Cardiovascular risk scores are widely used for risk stratification but may fail to identify a substantial proportion of individuals with subclinical atherosclerosis who are at increased risk of future cardiovascular events. Vascular ultrasound can directly detect carotid and femoral atherosclerotic plaques but its implementation is limited by the need for trained operators and expert interpretation. The AI-THEROSCOPE study aims to develop and validate an artificial intelligence-based tool capable of detecting subclinical atherosclerosis through the analysis of non-mydriatic retinal fundus images. Participants undergo clinical assessment, laboratory testing, carotid and femoral ultrasound, and retinal fundus photography. The performance of the AI model will be evaluated against vascular ultrasound findings as the reference standard for the presence of subclinical atherosclerosis.
Official title: Development and Validation of an AI-Based Tool to Detect Subclinical Atherosclerosis Using Non-Mydriatic Retinal Fundus Images: The AI-THEROSCOPE Project
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
884
Start Date
2023-10-01
Completion Date
2028-01-01
Last Updated
2026-06-10
Healthy Volunteers
No
Locations (1)
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain