Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07438327

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Aneurysm Abdominal Aortic Aneurysm and Dissection Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Aorta AIM Automated Measurement

Diagnostic Test

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.

Other names: Aorta AIM

Expert Radiologist Manual Measurement

Diagnostic Test

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 outcomes

  1. 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)

    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

Secondary outcomes

  1. Bland-Altman Limits of Agreement

    Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)

    Bland-Altman analysis to determine the limits of agreement between Aorta AIM automated measurements and expert manual measurements, providing assessment of systematic bias and random variation between the two measurement methods established through dual independent blinded reads with adjudication

  2. Intraclass Correlation Coefficient (ICC)

    Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)

    Intraclass Correlation Coefficient assessing the reliability and agreement between Aorta AIM automated measurements and expert manual measurements across all anatomical regions of the aorta established through dual independent blinded reads with adjudication

  3. Yield

    Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)

    Proportion of cases with valid ground truth for which Aorta AIM produces evaluable measurements at all predefined anatomical landmarks

  4. Processing time

    Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)

    Time required for Aorta AIM software to process CT scans and generate automated aortic diameter measurements, measured in seconds or minutes from image input to final measurement output.

  5. Qualitative clinical acceptability scores by expert readers

    Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)

    Expert radiologist assessment of the clinical acceptability of Aorta AIM automated measurements using standardized scoring criteria. Readers will evaluate whether automated measurements are suitable for clinical decision-making purposes. Clinical Acceptability Scale (0-2): 0 = Not Acceptable, 1 = Acceptable, 2 = Perfect. Higher scores indicate better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Jack Parker

CONTACT

[email protected]

4578313729 ext. 358

Scott Flamm, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Aiatella Oy

Industry

Registry information

Official study title

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

Acronym: AI-CARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.