AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation (NCT07438327) | Clinical Trial Compass
RecruitingNot Applicable
AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
United States, Brazil250 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Absolute Error (MAE) between Aorta AIM measurements and expert reference standard
Timeframe: At time of CT scan analysis (single time point, retrospective data collection from studies performed January 1, 2016 through August 31, 2025)