A Study of AI in Cardiac Transplant in Echocardiographic Analysis (ORACLE)
ORACLE
Outcome Reflection for Immune Mediated Rejection by Utilizing Artificial Intelligence in Cardiac Transplant Patients Through Early and Late Echocardiographic Analysis (ORACLE)
1 other identifier
observational
500
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2023
CompletedFirst Posted
Study publicly available on registry
December 21, 2023
CompletedStudy Start
First participant enrolled
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedJune 8, 2025
June 1, 2025
2.1 years
December 12, 2023
June 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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%
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
Eligibility Criteria
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.
You may qualify if:
- Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.
You may not qualify if:
- Refusal of study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Atta Behfar, MD, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 12, 2023
First Posted
December 21, 2023
Study Start
April 4, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share