Actively Recruiting

Age: 22Years +
All Genders
Healthy Volunteers
NCT07438327

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation

Led by Aiatella Oy · Updated on 2026-04-06

250

Participants Needed

3

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation

Who Can Participate

Age: 22Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 22 years or older at the time of imaging
  • CT scans performed between January 1, 2016 and August 31, 2025
  • CT imaging includes the whole, thoracic, or abdominal aorta with or without contrast
  • Slice thickness of CT scans is 3 mm or less
  • Partial aortic coverage is allowed if other regions are fully captured for measurement
Not Eligible

You will not qualify if you...

  • CT scans with truncation causing discontinuity within targeted aortic regions preventing measurement
  • Metal implants located less than 5 cm from the aorta (e.g., thoracic stent)
  • Prior aortic surgery
  • Severe motion artifacts such as vessel blurring greater than 3 mm
  • Congenital aortic anomalies such as coarctation or vascular rings
  • Post-traumatic aortic repairs
  • Patients who opted out of having their data used for medical research before site cross-referencing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Not Yet Recruiting

2

Innovation Health Services

Norfolk, Virginia, United States, 23510

Actively Recruiting

3

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil, 05652-900

Not Yet Recruiting

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Research Team

J

Jack Parker

CONTACT

S

Scott Flamm, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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