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

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

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

• Aiatella Oy

  lead INDUSTRY

Principal Investigators

• Jack Parker · Aiatella Oy

• Scott Flamm · SimonMed Imaging

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2026-08-30

Completion

2026-09-05

FDA Device

Yes

Countries

• United States
• Brazil

Study Locations