AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation

This study, called AI-CARE, is testing a new artificial intelligence (AI) software called Aorta AIM. Aorta AIM is designed to automatically measure the size of your aorta (the body's main blood vessel) from CT scans. An enlarged aorta, or aortic aneurysm, can lead to serious health problems. Currently, doctors measure the aorta manually, which can be time-consuming and vary between different doctors. This study wants to see how well Aorta AIM's measurements compare to those made by experienced radiologists. The study is looking for adults aged 22 and older who have had a CT scan of their aorta between January 2016 and August 2025. The goal is to see if Aorta AIM can provide accurate and consistent measurements.

Study design
This is an observational study that will compare measurements from the Aorta AIM software to those made by expert radiologists. It plans to include 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken at the time of the CT scan analysis, which is a single time point using retrospective data.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07438327

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation

Recruiting
Not specifiedAges 22+Observational
Aiatella Oy
~250 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Aorta AIM Automated MeasurementExpert Radiologist Manual Measurement

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard
Measured over At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Aortic Aneurysm
Aortic Aneurysm Abdominal
Aortic Aneurysm and Dissection
Aortic Aneurysm, Thoracoabdominal
3 sites across 3 states
North Carolina1
Virginia1
São Paulo1
  • Jack Parker · STUDY_DIRECTOR · Aiatella Oy
  • Scott Flamm · PRINCIPAL_INVESTIGATOR · SimonMed Imaging

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

    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