Subclinical AtherosclerosisAtheroscopeNCT07628088
AI-THEROSCOPE: AI Detection of Subclinical Atherosclerosis From Retinal Images
An observational study of Subclinical Atherosclerosis and Cardiovascular Risk, run by Infanta Leonor University Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclinical Atherosclerosis, Cardiovascular Risk
- How many people
- 884 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of an AI-Based Tool to Detect Subclinical Atherosclerosis Using Non-Mydriatic Retinal Fundus Images: The AI-THEROSCOPE Project
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.
Read the detailed description
Cardiovascular disease remains the leading cause of mortality worldwide. Current cardiovascular risk prediction models are useful for population-level risk estimation but may underestimate risk in a substantial proportion of individuals who already have subclinical atherosclerosis. Vascular ultrasound of the carotid and femoral arteries allows direct visualization of atherosclerotic plaques and improves cardiovascular risk stratification, but its widespread use is limited by the requirement for specialized equipment and trained personnel.
Retinal fundus imaging provides a non-invasive assessment of the microvasculature and has emerged as a promising tool for cardiovascular risk evaluation. Recent advances in artificial intelligence and deep learning have demonstrated the ability of retinal image analysis to identify cardiovascular risk factors and predict cardiovascular outcomes.
The AI-THEROSCOPE study is a prospective observational study designed to develop and validate an artificial intelligence model for the detection of subclinical atherosclerosis using non-mydriatic retinal fundus photographs. Adult participants without previous cardiovascular disease undergo standardized clinical evaluation, laboratory testing, carotid and femoral vascular ultrasound, and bilateral retinal fundus photography.
The presence of carotid and/or femoral atherosclerotic plaque assessed by vascular ultrasound serves as the reference standard. Deep learning techniques will be used to train and validate predictive models based on retinal images. Model performance will be evaluated using discrimination metrics including the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value.
The ultimate objective of the project is to develop a scalable, non-invasive, and easily deployable tool that may facilitate early detection of subclinical atherosclerosis and improve cardiovascular risk stratification in clinical practice and population screening programs.
- Conditions
- Subclinical Atherosclerosis, Cardiovascular Risk
- Keywords
- Artificial Intelligence, Deep Learning, Retinal Imaging, Non-Mydriatic Fundus Camera, Carotid Plaque, Femoral Plaque, Subclinical Atherosclerosis, Oculomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Undergoing Retinal Imaging and Vascular Ultrasound | Adult participants without previous established cardiovascular disease who undergo standardized cardiovascular risk assessment, laboratory testing, bilateral carotid and femoral vascular ultrasound, and non-mydriatic retinal fundus photography. The cohort is used for the development and validation of an artificial intelligence model for the detection of subclinical atherosclerosis using retinal fundus images. The presence of carotid and/or femoral atherosclerotic plaque assessed by vascular ultrasound serves as the reference standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUC) for Detection of Subclinical Atherosclerosis
Diagnostic performance of the artificial intelligence model based on non-mydriatic retinal fundus images for detecting carotid and/or femoral atherosclerotic plaques, using vascular ultrasound as the reference standard.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Oct 2023
- Primary completion1 Jan 2026
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 884 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infanta Leonor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabel Franco Moreno, Infanta Leonor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628088
- Sponsor's protocol ID
- Atheroscope_HUIL
- Acronym
- Atheroscope
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared. De-identified data may be made available upon reasonable request to the principal investigator, subject to institutional policies, ethical approval, data protection regulations, and applicable legal requirements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an AI-Based Tool to Detect Subclinical Atherosclerosis Using Non-Mydriatic Retinal Fundus Images: The AI-THEROSCOPE Project
- ClinicalTrials.gov ID
- NCT07628088
- Acronym / sponsor ID
- Atheroscope / Atheroscope_HUIL
- Conditions
- Subclinical Atherosclerosis, Cardiovascular Risk
- Keywords
- Artificial Intelligence, Deep Learning, Retinal Imaging, Non-Mydriatic Fundus Camera, Carotid Plaque, Femoral Plaque, Subclinical Atherosclerosis, Oculomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 884 participants (estimated)
- Lead sponsor
- Infanta Leonor University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease remains the leading cause of mortality worldwide. Current cardiovascular risk prediction models are useful for population-level risk estimation but may underestimate risk in a substantial proportion of individuals who already have subclinical atherosclerosis. Vascular ultrasound of the carotid and femoral arteries allows direct visualization of atherosclerotic plaques and improves cardiovascular risk stratification, but its widespread use is limited by the requirement for specialized equipment and trained personnel.
Retinal fundus imaging provides a non-invasive assessment of the microvasculature and has emerged as a promising tool for cardiovascular risk evaluation. Recent advances in artificial intelligence and deep learning have demonstrated the ability of retinal image analysis to identify cardiovascular risk factors and predict cardiovascular outcomes.
The AI-THEROSCOPE study is a prospective observational study designed to develop and validate an artificial intelligence model for the detection of subclinical atherosclerosis using non-mydriatic retinal fundus photographs. Adult participants without previous cardiovascular disease undergo standardized clinical evaluation, laboratory testing, carotid and femoral vascular ultrasound, and bilateral retinal fundus photography.
The presence of carotid and/or femoral atherosclerotic plaque assessed by vascular ultrasound serves as the reference standard. Deep learning techniques will be used to train and validate predictive models based on retinal images. Model performance will be evaluated using discrimination metrics including the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value.
The ultimate objective of the project is to develop a scalable, non-invasive, and easily deployable tool that may facilitate early detection of subclinical atherosclerosis and improve cardiovascular risk stratification in clinical practice and population screening programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Undergoing Retinal Imaging and Vascular Ultrasound | – | –Adult participants without previous established cardiovascular disease who undergo standardized cardiovascular risk assessment, laboratory testing, bilateral carotid and femoral vascular ultrasound, and non-mydriatic retinal fundus photography. The cohort is used for the development and validation of an artificial intelligence model for the detection of subclinical atherosclerosis using retinal fundus images. The presence of carotid and/or femoral atherosclerotic plaque assessed by vascular ultrasound serves as the reference standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) for Detection of Subclinical Atherosclerosis
Time frame: Baseline
Diagnostic performance of the artificial intelligence model based on non-mydriatic retinal fundus images for detecting carotid and/or femoral atherosclerotic plaques, using vascular ultrasound as the reference standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared. De-identified data may be made available upon reasonable request to the principal investigator, subject to institutional policies, ethical approval, data protection regulations, and applicable legal requirements.
Related trials for Subclinical Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 4
Feasibility of Combination Therapy With Low-dose Statin and Ezetimibe in Patients With Minimal Subclinical Atherosclerosis
Atherosclerosis Cardiovascular Disease
RecruitingPhase 3
Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
Coronary Artery Disease, Subclinical Atherosclerotic Cardiovascular Disease
Not yet recruitingObservational study
Non Invasive Assessment of Subclinical Atherosclerosis and Cardiovascular Risk Using TYG Index in Lupus Nephritis
Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN)
Active, not recruitingObservational study
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT
Atherosclerosis, Subclinical Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Atherosclerosis and Cardiovascular Risk, run by Infanta Leonor University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUC) for Detection of Subclinical Atherosclerosis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.