Actively Recruiting
AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)
Led by Aiatella Oy · Updated on 2026-04-06
250
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy and efficiency of an artificial intelligence (AI) software called Aorta AIM in measuring the size of the aorta, the body's main blood vessel, using CT scans. The study focuses on comparing Aorta AIM's automated measurements with those made manually by experienced radiologists or cardiologists. This research aims to improve how doctors monitor aortic enlargement, which can lead to serious health problems, by providing a consistent and faster measurement method. The study involves retrospectively collecting chest or abdominal CT scans from adults aged 22 and older taken as part of routine medical care between January 1, 2016, and August 31, 2025. These scans will be analyzed by both the Aorta AIM software and expert radiologists who manually measure aortic diameters. The software provides standardized measurements at specific anatomical locations, and any discrepancies between manual readers are resolved by a senior expert for an accurate reference standard. Participants have already undergone CT imaging, so no additional scans or procedures are required. Researchers will review the collected data to compare measurement accuracy, processing time, and clinical acceptability of the AI software against expert assessments. The main outcome is the average difference between AI and expert measurements. Secondary outcomes include agreement limits, measurement reliability, software yield, processing speed, and expert clinical acceptability scores. The study includes about 250 participants from multiple hospitals, with no risks since only existing images are used.
CONDITIONS
Brief Title
AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 2 years or older at time of imaging
- CT imaging performed between January 1, 2016, and August 31, 2025
- CT scans of whole, thoracic, or abdominal aorta with or without contrast
- Slice thickness of 3 mm or less
- CT scans with partial aortic coverage allowed except for regions with truncation
- Metal implants less than 5 cm from the aorta
- No severe motion artifacts (less than or equal to 3 mm vessel blurring)
You will not qualify if you...
- Truncation causing discontinuity preventing reliable diameter measurement in aortic regions
- Prior aortic surgery
- Severe motion artifacts exceeding 3 mm vessel blurring
- Congenital aortic anomalies such as coarctation or vascular rings
- Post-traumatic aortic repairs
- Patient opted out of medical research data use before cross-referencing date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility confirmation
Duration - Single time point retrospective data collection
Participants' previously collected CT scans of the aorta are analyzed using investigational artificial intelligence software and expert radiologists to measure aortic diameters.
No additional visits; analysis performed on existing CT scans
Duration - Data collected from scans performed between January 1, 2016, and August 31, 2025
Participants who underwent routine clinical CT imaging are observed retrospectively for validation of automated aortic measurements compared to expert manual measurements.
No participant visits; observational data only
Trial Site Locations
Total: 3 locations
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
2
Innovation Health Services
Norfolk, Virginia, United States, 23510
Actively Recruiting
3
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05652-900
Not Yet Recruiting
Research Team
J
Jack Parker
S
Scott Flamm, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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