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

Recruiting

• Conditions: Cardiac Transplant Rejection

• Registration Number: NCT06178744
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-21
• Study Start: 2024-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States