Clinical trial Recruiting at 1 site Observational Ages 22 and up

Using AI to measure aortic size from CT scans

Official title: AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)

Run by Aiatella Oy · NCT07438327 · Data updated 2026-11-12

This project will test whether an AI tool called Aorta AIM can automatically measure the aorta on CT scans for adults who have or are being checked for aortic aneurysms.

Quick facts

Study typeObservational
Ages22 Years and up
SexAll
Enrollment250 (estimated)
SponsorAiatella Oy
Industry-sponsored
Locations3 sites (Chapel Hill, North Carolina and 2 other locations)
StatusRecruiting
StartedMarch 31, 2026
Main results expectedAugust 30, 2026
Study endsSeptember 5, 2026
Registry record updatedApril 6, 2026
Trial IDNCT07438327 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (≥22 years at imaging) who have a CT scan capturing the whole, thoracic, or abdominal aorta (slice thickness ≤ 3 mm) performed between 2016 and August 2025, including exams with or without contrast.

Probably not a fit

Patients whose CT images have severe motion artifacts, congenital aortic anomalies, recent prior aortic surgery, metal implants very close to the aorta, or imaging truncation that prevents reliable regional measurements may not benefit from the AI analysis.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares automated aortic diameter measurements from an AI software (Aorta AIM) with manual measurements made by experienced radiologists or cardiologists using existing CT scans. Researchers will use retrospective CT images collected between January 1, 2016 and August 31, 2025 from multiple hospitals in the United States and Brazil, including whole, thoracic, or abdominal aorta exams with slice thickness ≤ 3 mm. No new scans or procedures are required; the AI and expert measurements will be compared region-by-region, excluding only areas with truncation or poor image quality that prevent reliable measurement. Approximately 250 adult participants (age ≥ 22 at imaging) will be included to test the AI’s consistency and agreement with human readers.

Why it matters

Potential benefit: If successful, the AI could provide faster, more consistent aortic measurements that help clinicians monitor aneurysm growth and make treatment decisions sooner.

How similar studies have gone: Other research using AI for vascular segmentation and diameter measurement has shown promising accuracy in controlled settings, though such tools are not yet universally adopted in routine clinical practice.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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)

  o 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

Where it's running

  • Innovation Health Services
    Norfolk, Virginia, United States
    Recruiting
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina, United States
    Not yet recruiting
  • Hospital Israelita Albert Einstein
    São Paulo, São Paulo, Brazil
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.