CLAiR Pivotal Study for ASCVD Risk Identification
This study is looking at how well a special artificial intelligence (AI) software called CLAiR can identify your risk of developing atherosclerotic cardiovascular disease (ASCVD), which is a type of heart disease. CLAiR uses images of your retina (the back of your eye) to do this. You would have retinal images taken, which are then analyzed by the CLAiR software. There are no medical interventions involved. This study aims to see if CLAiR can accurately tell if you have an elevated ASCVD risk, compared to a standard risk score used by doctors. People aged 40 to 75 can join, as long as they can understand and agree to the study procedures. The study is considered successful if CLAiR can accurately identify elevated ASCVD risk. The current recruitment status is unclear.
- Study design
- This is an observational study involving 942 participants. It is designed to compare the CLAiR software's performance against a standard risk score.
- What's involved
- You would need to provide informed consent and have retinal images obtained. You would also need to be available for the duration of the study, which averages 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured through study completion, which averages 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CLAiR Pivotal Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael McConnell, MD · STUDY_DIRECTOR · Toku Inc.
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.through study completion, an average of 6 months
Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%