Abdominal Aortic Aneurysm (AAA) Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:

• 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)

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Virginia
Innovation Health Services
RECRUITING
Norfolk
Other Locations
Brazil
Hospital Israelita Albert Einstein
NOT_YET_RECRUITING
São Paulo
Contact Information
Primary
Jack Parker
jack@aiatella.com
4578313729
Backup
Scott Flamm, MD
Time Frame
Start Date: 2026-03-31
Estimated Completion Date: 2026-09-05
Participants
Target number of participants: 250
Treatments
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.
Sponsors
Leads: Aiatella Oy

This content was sourced from clinicaltrials.gov