RecruitingNCT07438327

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

Sponsor: Aiatella Oy

Trial Details

ConditionAortic Aneurysm, Aortic Aneurysm Abdominal, Aortic Aneurysm and Dissection, Aortic Aneurysm, Thoracoabdominal
InterventionAorta AIM Automated Measurement; Expert Radiologist Manual Measurement
StatusRecruiting
Participants250
Est. Completion30 Aug 2026
Last Updated6 Apr 2026

Primary Outcome

Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

United StatesBrazil
View Registry Entry

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