AI eye scans could reveal hidden heart risk
NCT ID NCT07747233
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This study is testing whether an artificial intelligence software called CLAiR can reliably identify people at elevated risk for heart disease by analyzing images of the back of the eye (retina). The software looks for patterns in retinal images that may correlate with cardiovascular risk. Participants, who are adults aged 40 to 75 without known heart disease, will have retinal images taken with specific cameras. The main goal is to see if the software gives consistent results when different operators take the images, which is a key step toward using it as a screening tool.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CLAiR artificial intelligence software (a medical device that analyzes retinal images)
- What this could lead to
- If successful, this could lead to a quick, non-invasive way to screen for heart disease risk during routine eye exams, potentially catching problems earlier.
- What could go wrong
- This is a small, early-stage study focused on accuracy and consistency, not on patient outcomes. The software may not perform as well in broader populations or real-world settings.
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.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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56 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed. Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit. Exclusion Criteria: Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting. Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity \<20/400). Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one eye.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Diabetes and Endocrinology Associates of Stark County, Inc.
Canton, Ohio, 44718, United States
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Illinois Retina Associates
Homer Glen, Illinois, 60491, United States
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