Aortic AneurysmAI-CARENCT07438327
AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
An observational study of Aortic Aneurysm and Aortic Aneurysm Abdominal, run by Aiatella Oy at 3 sites in 2 countries.
Trial summary
This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans. The aorta can become enlarged over time, which may lead to serious health problems. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Aortic Aneurysm and Dissection
- What is being tested?
- Aorta AIM Automated Measurement and Expert Radiologist Manual Measurement
- How many people
- 250 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 31 Mar 2026to 5 Sep 2026
- Phase
- Observational
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥22 years of age) who underwent CT imaging of the aorta (whole, thoracic, or abdominal) as part of routine clinical care between January 1, 2016 and August 31, 2025. CT scans must include imaging of the aorta with or without contrast enhancement and have slice thickness ≤3mm. Patients with metal implants within 5cm of the aorta, prior aortic surgery, severe motion artifacts, congenital aortic anomalies, or post-traumatic aortic repairs are excluded. Patients who opted out of having their data used for medical research are also excluded. Retrospectively collected, de-identified CT imaging data from approximately 250 cases across multiple international sites in the United States and Latin America will be analyzed.
- Adults ≥22 years at time of imaging
- Studies performed 1 Jan 2016 - 31 August 2025
- CT imaging of the whole, thoracic, or abdominal aorta, with or without contrast enhancement, acquired with any gating protocol (including non-gated)
- Slice thickness ≤ 3mm
- CT imaging in which truncation creates discontinuity within a targeted aortic region, preventing reliable diameter measurement (e.g., cardiac-focused CT acquisitions where an incomplete or absent aortic arch creates discontinuity between the aortic root and the descending thoracic aorta)
- Partial aortic coverage is not grounds for exclusion. Where truncation affects individual regions, only those specific regions will be excluded from analysis; remaining fully captured regions will be retained for measurement.
- Metal implants <5cm from aorta (e.g. thoracic stent)
- Prior aortic surgery
- Severe motion artifacts (e.g. >3mm vessel blurring)
- Congenital aortic anomalies (e.g. coarctation, vascular rings)
- Post-traumatic aortic repairs
- The patient opted out of having their data used for medical research before the date of cross-referencing by the site team
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Scott Flamm, MD contact
3 sites in 2 countries
United States2 sites, 2 recruiting
- Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Dr. Behrooz Masuodi, 919-962-2211
Dr. Behrooz Masuodi
- Recruiting
Innovation Health Services
Norfolk, Virginia, 23510
Dr. Huma Samar, MD, 888-784-4763, info@ihsmd.org
Dr. Huma Samar
Brazil1 site, 1 recruiting
- Not yet recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
Dr. Henrique Lee, MD, +55 (11) 2151-0222, sac@einstein.br
Dr. Henrique Lee
About this study
Official title: AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)
This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans. The aorta can become enlarged over time, which may lead to serious health problems. Doctors need to measure the aorta accurately to monitor patients and decide on treatment.
Currently, doctors measure the aorta manually on CT scans, which takes time and can vary between different doctors. Aorta AIM is designed to measure the aorta automatically and consistently.
Read more
In this study, researchers will compare Aorta AIM's measurements to those made by experienced radiologists or cardiologists (doctors who specialize in reading medical images). The study will use CT scans that have already been taken as part of routine medical care - no additional scans or procedures are needed.
The study will include approximately 250 participants across multiple hospitals in Brazil and the United States. Participants will be adults who have had a chest or abdominal CT scan that shows their aorta.
The main goals are to:
- Check if Aorta AIM measures the aorta as accurately as radiologists
- See if Aorta AIM can help doctors work more efficiently
- Evaluate if the software works well in different hospital settings and with different types of patients
This research may help improve how doctors monitor aortic disease and make treatment decisions in the future. There are no risks to participants since the study only uses existing medical images.
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Aortic Aneurysm and Dissection, Aortic Aneurysm, Thoracoabdominal
- Being tested
- Aorta AIM Automated Measurement, Expert Radiologist Manual Measurement
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Abdominal, Aortic Dissection, Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aorta AIM Automated MeasurementDiagnostic test
Also called Aorta AIM
Aorta AIM is an investigational artificial intelligence software that automatically measures aortic diameters from CT imaging. The software analyzes retrospectively collected CT scans and generates standardized aortic diameter measurements at anatomically defined locations. These automated measurements will be compared to manual measurements performed by expert radiologists.
Expert Radiologist Manual MeasurementDiagnostic test
Manual aortic diameter measurements performed independently by two board-certified or equivalently experienced radiologists (minimum 5 years of cardiovascular imaging experience), each blinded to the other's measurements. Where the difference between the two reads does not exceed 3mm, the mean serves as the ground truth. Where the difference exceeds 3mm, a third senior reader performs independent adjudication, blinded to both primary reads. These consensus measurements serve as the reference standard for validation
| Study group | Role | What they receive |
|---|---|---|
| Validation Cohort | Adults who have undergone chest or abdominal CT imaging (with or without contrast) as part of routine clinical care. CT scans will be retrospectively collected and processed by both Aorta AIM software and expert radiologists to validate automated aortic diameter measurements. Receives: Diagnostic Test: Aorta AIM Automated Measurement; Diagnostic Test: Expert Radiologist Manual Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard
Mean Absolute Error (MAE) between aortic diameter measurements generated by Aorta AIM version 1.0 and the reference standard established by board-certified or equivalently experienced radiologists and/or cardiologists. Reference standard established through dual independent blinded reads with adjudication by a third senior reader where required. MAE will be calculated across all anatomical regions of the aorta assessed in the study. Acceptance criterion: MAE ≤ 5.0mm
Measured: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Secondary outcomes (5)
Bland-Altman Limits of Agreement
Bland-Altman analysis to determine the limits of agreement between Aorta AIM automated measurements and expert manual measurements, providing assessment of systematic bias and random variation between the two measurement methods established through dual independent blinded reads with adjudication
Measured: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Intraclass Correlation Coefficient (ICC)
Intraclass Correlation Coefficient assessing the reliability and agreement between Aorta AIM automated measurements and expert manual measurements across all anatomical regions of the aorta established through dual independent blinded reads with adjudication
Measured: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Yield
Proportion of cases with valid ground truth for which Aorta AIM produces evaluable measurements at all predefined anatomical landmarks
Measured: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Processing time
Time required for Aorta AIM software to process CT scans and generate automated aortic diameter measurements, measured in seconds or minutes from image input to final measurement output.
Measured: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Qualitative clinical acceptability scores by expert readers
Expert radiologist assessment of the clinical acceptability of Aorta AIM automated measurements using standardized scoring criteria. Readers will evaluate whether automated measurements are suitable for clinical decision-making purposes. Clinical Acceptability Scale (0-2): 0 = Not Acceptable, 1 = Acceptable, 2 = Perfect. Higher scores indicate better outcome.
Measured: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start31 Mar 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiatella Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack Parker, Study director, Aiatella OyScott Flamm, Principal investigator, SimonMed Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438327
- Sponsor's protocol ID
- CRS_001_AI-CARE_US_LATAM
- Acronym
- AI-CARE
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a retrospective medical device validation study using de-identified CT imaging data. Individual participant data cannot be shared due to patient privacy protections, institutional data use agreements, and proprietary algorithm considerations. Aggregate study results, including device performance metrics and statistical analyses, will be made publicly available through peer-reviewed publication and regulatory submissions.