AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aiatella Oy
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard
概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Aorta AIM Automated Measurement (Diagnostic Test)
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.
干预措施: Expert Radiologist Manual Measurement (Diagnostic Test)
结局指标
主要结局
Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard
时间窗: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)
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
次要结局
- Bland-Altman Limits of Agreement(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)(At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025))
- Yield(At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025))
- Processing time(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(At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025))