🏛️ Verified NIH Record • Updated 2026-03-31

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation (NCT07438327)

AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Aiatella Oy

🩺 Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: University of North Carolina at Chapel Hill — Chapel Hill, North Carolina

Age range: 22 Years

🧪 Interventions in This Study

  • Aorta AIM Automated Measurement (DIAGNOSTIC_TEST)
  • Expert Radiologist Manual Measurement (DIAGNOSTIC_TEST)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (3 Sites)

  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
  • Innovation Health Services — Norfolk, Virginia
  • Hospital Israelita Albert Einstein — São Paulo, São Paulo

📞 Contact the Study Coordinator

Phone: (457) 831-3729

Email: jack@aiatella.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Aortic Aneurysm clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗