An observational study in Aortic Aneurysm, Aortic Aneurysm Abdominal and Aortic Aneurysm and Dissection, sponsored by Aiatella Oy. Recruiting at 3 sites in 2 countries. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Aiatella Oy · Observational
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:
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.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →This is the only study on the registry with Aiatella Oy as lead sponsor.
Compared within Aortic Aneurysm, Thoracoabdominal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
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
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
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
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 radiologists and/or cardiologists. Reference standard established through dual independent blinded reads with adjudication by a third senior reader where required. MAE will be calculated across all anatomical regions of the aorta assessed in the study. Acceptance criterion: MAE ≤ 5.0mm
Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Bland-Altman Limits of Agreement
Bland-Altman analysis to determine the limits of agreement between Aorta AIM automated measurements and expert manual measurements, providing assessment of systematic bias and random variation between the two measurement methods established through dual independent blinded reads with adjudication
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)
Intraclass Correlation Coefficient assessing the reliability and agreement between Aorta AIM automated measurements and expert manual measurements across all anatomical regions of the aorta established through dual independent blinded reads with adjudication
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
Proportion of cases with valid ground truth for which Aorta AIM produces evaluable measurements at all predefined anatomical landmarks
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 required for Aorta AIM software to process CT scans and generate automated aortic diameter measurements, measured in seconds or minutes from image input to final measurement output.
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
Expert radiologist assessment of the clinical acceptability of Aorta AIM automated measurements using standardized scoring criteria. Readers will evaluate whether automated measurements are suitable for clinical decision-making purposes. Clinical Acceptability Scale (0-2): 0 = Not Acceptable, 1 = Acceptable, 2 = Perfect. Higher scores indicate better outcome.
Time frame: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
Plan to share: No — This is a retrospective medical device validation study using de-identified CT imaging data. Individual participant data cannot be shared due to patient privacy protections, institutional data use agreements, and proprietary algorithm considerations. Aggregate study results, including device performance metrics and statistical analyses, will be made publicly available through peer-reviewed publication and regulatory submissions.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Aug 2026, 4 months after the start.
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