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

NCT07628088 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 884

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Subclinical Atherosclerosis
  • Cardiovascular Risk

Sponsors & Collaborators

  • Infanta Leonor University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-01-01
Completion
2028-01-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628088 on ClinicalTrials.gov