NCT07438327 AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
| NCT ID | NCT07438327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aiatella Oy |
| Condition | Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2026-03-31 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Jack Parker
STUDY DIRECTOR
Aiatella Oy
Frequently Asked Questions
Who can join the NCT07438327 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07438327 currently recruiting?
Yes, NCT07438327 is actively recruiting participants. Contact the research team at jack@aiatella.com for enrollment information.
Where is the NCT07438327 trial being conducted?
This trial is being conducted at Chapel Hill, United States, Norfolk, United States, São Paulo, Brazil.
Who is sponsoring the NCT07438327 clinical trial?
NCT07438327 is sponsored by Aiatella Oy. The principal investigator is Jack Parker at Aiatella Oy. The trial plans to enroll 250 participants.