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

Conditions

• Aortic Aneurysm
• Aortic Aneurysm Abdominal
• Aortic Aneurysm and Dissection
• Aortic Aneurysm, Thoracoabdominal

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.
• 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

Study Details

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.

Key Dates

Start date

Mar 31, 2026

Status verified

Mar 2026

Primary completion

Aug 30, 2026

Completion

Sep 5, 2026

Study Design

Enrollment

250 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

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) ]

Central Contacts

• Jack Parker
  4578313729
  [email protected]
• Scott Flamm, MD

Locations (2)

Find similar trials in Chapel Hill, NC

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