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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm Abdominal; Aortic Aneurysm and Dissection
• Intervention / Treatment: Diagnostic test: Aorta AIM Automated Measurement; Diagnostic test: Expert Radiologist Manual Measurement

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Scott Flamm, MD
• Study Contact Backup: Name: Jack Parker; Phone Number: 358 4578313729; Email: jack@aiatella.com

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05652-900
      • Not yet recruiting
      • Hospital Israelita Albert Einstein
      • Contact: Dr. Henrique Lee, MD; Phone Number: +55 (11) 2151-0222; Email: sac@einstein.br
      • Principal Investigator: Dr. Henrique Lee
• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Not yet recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Dr. Behrooz Masuodi; Phone Number: 919-962-2211
      • Principal Investigator: Dr. Behrooz Masuodi
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Recruiting
      • Innovation Health Services
      • Contact: Dr. Huma Samar, MD; Phone Number: 888-784-4763; Email: info@ihsmd.org
      • Principal Investigator: Dr. Huma Samar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥22 years of age) who underwent CT imaging of the aorta (whole, thoracic, or abdominal) as part of routine clinical care between January 1, 2016 and August 31, 2025. CT scans must include imaging of the aorta with or without contrast enhancement and have slice thickness ≤3mm. Patients with metal implants within 5cm of the aorta, prior aortic surgery, severe motion artifacts, congenital aortic anomalies, or post-traumatic aortic repairs are excluded. Patients who opted out of having their data used for medical research are also excluded. Retrospectively collected, de-identified CT imaging data from approximately 250 cases across multiple international sites in the United States and Latin America will be analyzed.

Description

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: Aorta AIM; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Processing time	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.	At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Bland-Altman Limits of Agreement	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	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 (ICC)	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	At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Yield	Proportion of cases with valid ground truth for which Aorta AIM produces evaluable measurements at all predefined anatomical landmarks	At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Qualitative clinical acceptability scores by expert readers	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.	At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)

Collaborators and Investigators

• Sponsor: Aiatella Oy
• Investigators: Study Director: Jack Parker, Aiatella Oy; Principal Investigator: Scott Flamm, SimonMed Imaging

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 5, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CRS_001_AI-CARE_US_LATAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a retrospective medical device validation study using de-identified CT imaging data. Individual participant data cannot be shared due to patient privacy protections, institutional data use agreements, and proprietary algorithm considerations. Aggregate study results, including device performance metrics and statistical analyses, will be made publicly available through peer-reviewed publication and regulatory submissions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No