RecruitingNCT07438327

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

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

Sponsor

Aiatella Oy

Enrollment

250 participants

Start Date

Mar 31, 2026

Study Type

OBSERVATIONAL

Conditions

Aortic Aneurysm

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.

Eligibility

Min Age: 22 Years

Inclusion Criteria12

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

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Interventions

DIAGNOSTIC_TESTAorta 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_TESTExpert 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