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AI in Cardiac Transplant Echocardiographic Analysis (ORACLE)

This study, called ORACLE, is looking at how well Artificial Intelligence (AI) can help detect rejection after a heart transplant. Researchers are using AI to analyze data from your electrocardiogram (ECG, a test that checks your heart's electrical activity) and cardiac ultrasound (echocardiogram, a test that uses sound waves to create images of your heart). The goal is to see if the AI can accurately identify episodes of rejection, such as acute cellular rejection or antibody-mediated rejection, or a significant drop in your heart's pumping ability. You may be able to join if you are 18 or older, have had a heart transplant, and are undergoing a post-transplant endomyocardial biopsy (a procedure to take a small tissue sample from your heart). The study aims to enroll 500 participants.

Study design
This is an observational study with a planned enrollment of 500 participants. It is not specified if it is a specific phase of research.
What's involved
You would need to be undergoing a post-cardiac transplant endomyocardial biopsy and provide informed consent for the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures are assessed at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06178744

A Study of AI in Cardiac Transplant in Echocardiographic Analysis (ORACLE)

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~500 participants
Updated 2026-06-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to <50%, or a drop in LVEF >5%
Measured over 2 years

Conditions

Cardiac Transplant Rejection

Explore related trials

Cardiac transplant rejection

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Atta Behfar, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Alyssa Lokensgard
[email protected]
507-422-5123
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.

Exclusion

Refusal of study participation

What this trial measures

  • Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to <50%, or a drop in LVEF >5%2 years

    Number of episodes identified by the AI algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to \<50%, or a drop in LVEF \>5% utilizing electrocardiograms and cardiac ultrasound images/videos obtained from point of care ultrasound (POCUS) or echocardiograms.