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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06178744

Acronym

ORACLE

Enrollment

500

Registered

2023-12-21

Start date

2024-04-04

Completion date

2028-06-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Transplant Rejection

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTAlyssa Lokensgard

lokensgard.alyssa@mayo.edu507-422-5123

CONTACTAtta Behfar, MD, PhD

Behfar.Atta@mayo.edu507-266-0318

PRINCIPAL_INVESTIGATORAtta Behfar, MD, PhD

Mayo Clinic

Outcome results