Recruiting

Aorta AIM

Sponsor:

Aiatella Oy

Code:

NCT07438327

Conditions

Aortic Aneurysm

Aortic Aneurysm Abdominal

Aortic Aneurysm and Dissection

Aortic Aneurysm, Thoracoabdominal

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Aorta AIM Automated Measurement

Expert Radiologist Manual Measurement

Study Details

Brief 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. 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.

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

Study ID

NCT07438327

Start date

Mar 31, 2026

Status verified date

Mar, 2026

Completion date

Sep 5, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Aorta AIM Automated Measurement

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 Measurement

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

Primary outcome measure

  • Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard [ Time Frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025) ]

Central Contacts and Locations

Central contacts

Jack Parker

4578313729jack@aiatella.com

Locations

Innovation Health Services

Recruiting

Norfolk, Virginia, United States, 23510

Contacts

Dr. Huma Samar, MD

888-784-4763info@ihsmd.org

Principal Investigator:

Dr. Huma Samar

More Information

Sponsor

Aiatella Oy

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aiatella Oy on 2026-04-06.