AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
Purpose
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.
Conditions
- Aortic Aneurysm
- Aortic Aneurysm Abdominal
- Aortic Aneurysm and Dissection
- Aortic Aneurysm, Thoracoabdominal
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Norfolk, Virginia 23510
More Details
- Status
- Recruiting
- Sponsor
- Aiatella Oy