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

NCT07438327 | Not Yet Recruiting FDA Device

• 1 other identifier: CRS_001_AI-CARE_US_LATAM
• Study Type: observational
• Target: 240
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 expert radiologists performing manual annotations. MAE will be calculated across all anatomical regions of the aorta assessed in the study.

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

Secondary Outcomes (5)

• Bland-Altman Limits of Agreement

  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)

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

• Processing success rate

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

• Processing time

  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

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

Study Arms (1)

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; Diagnostic Test: Expert Radiologist Manual Measurement

Interventions

Expert Radiologist Manual Measurement DIAGNOSTIC_TEST

Manual aortic diameter measurements performed by experienced radiologists (minimum 5 years of cardiovascular imaging experience) using standard clinical measurement techniques on the same CT scans analyzed by Aorta AIM software. These measurements serve as the reference standard for validation.

Validation Cohort

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.

Also known as: Aorta AIM

Validation Cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults ≥22 years at time of imaging
• Studies performed 1 Jan 2016 - 31 August 2025
• CT imaging of whole, thoracic, or abdominal aorta with or without contrast enhancement:
• Non-contrast: cardiac-gated or non-gated
• Contrast-enhanced: cardiac-gated thoracic and/or non gated abdominal
• Slice thickness ≤ 3mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Aiatella Oy: lead

Study Sites (3)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Innovation Health Services

Norfolk, Virginia, 23510, United States

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Dissection; Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Jack Parker

  Aiatella Oy

  STUDY DIRECTOR

• Scott Flamm

  SimonMed Imaging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Parker

CONTACT

4578313729; jack@aiatella.com

Scott Flamm, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 2, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); US (2)