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

June 4, 2025 updated by: Atta Behfar MD, PhD, Mayo Clinic

Outcome Reflection for Immune Mediated Rejection by Utilizing Artificial Intelligence in Cardiac Transplant Patients Through Early and Late Echocardiographic Analysis (ORACLE)

The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram) and Cardiac Ultrasound (Echocardiogram and/or point of care ultrasound).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Atta Behfar, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Post-cardiac transplantation subjects, presenting to the cardiac catheterization laboratories at Mayo Clinic in Rochester, MN for routine surveillance biopsies or for diagnostic biopsies in the setting of clinical concern including rejection and graft dysfunction will be enrolled.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Atta Behfar, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 23-006378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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