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

Official title

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

Overview

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.

Interventions

• 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.
• 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 sta

Primary outcome measures

• 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)]

Secondary outcome measures (5)

• 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)]
• 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)]
• 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)]
• 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)]
• 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)]

Eligibility criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-only

Study locations

United States · 2 centers

• University of North Carolina at Chapel Hill — Chapel Hill
• Innovation Health Services — Norfolk

Brazil · 1 center

• Hospital Israelita Albert Einstein — São Paulo

Identifiers

NCT: NCT07438327 · CRS_001_AI-CARE_US_LATAM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗