AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)
Sponsor: Aiatella Oy
Trial Details
| Condition | Aortic Aneurysm, Aortic Aneurysm Abdominal, Aortic Aneurysm and Dissection, Aortic Aneurysm, Thoracoabdominal |
| Intervention | Aorta AIM Automated Measurement; Expert Radiologist Manual Measurement |
| Status | Recruiting |
| Participants | 250 |
| Est. Completion | 30 Aug 2026 |
| Last Updated | 6 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
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