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AI eye test spots silent artery disease before it strikes

NCT ID NCT07628088

Diagnosis Sponsor: Infanta Leonor University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is developing an artificial intelligence tool that can detect hidden plaque in arteries by analyzing photos of the retina (the back of the eye). About 884 adults without known heart disease will have eye photos taken and compared with ultrasound scans of their neck and leg arteries. The goal is to see if the AI can accurately identify people with early artery disease, potentially offering a quick, low-cost screening method.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 884 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults undergoing cardiovascular risk assessment at a university hospital cardiovascular risk unit and healthcare workers or relatives participating in cardiovascular screening programs. All participants undergo clinical evaluation, laboratory testing, carotid and femoral vascular ultrasound, and non-mydriatic retinal fundus photography.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 years or older. * No previous established cardiovascular disease. * Undergoing cardiovascular risk assessment and carotid and femoral vascular ultrasound. * Ability to provide written informed consent. Exclusion Criteria: * Previous acute coronary syndrome, stroke, or peripheral arterial disease. * Previous carotid or femoral vascular surgery or stenting. * Previous ophthalmologic surgery. * Retinal or ocular diseases that significantly affect retinal vasculature or image quality, including moderate or severe diabetic retinopathy, retinal vascular occlusion, advanced hypertensive retinopathy, exudative age-related macular degeneration, or macular edema. * Inability or unwillingness to provide informed consent.

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Conditions

The condition(s) this trial relates to.

atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular risk Subclinical atherosclerosis

Contacts and locations

Locations

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28031, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.