Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07628088

AI-THEROSCOPE: AI Detection of Subclinical Atherosclerosis From Retinal Images

Sponsor: Infanta Leonor University Hospital

View on ClinicalTrials.gov

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