Using AI to analyze heart transplant rejection through echocardiograms
Outcome Reflection for Immune Mediated Rejection by Utilizing Artificial Intelligence in Cardiac Transplant Patients Through Early and Late Echocardiographic Analysis (ORACLE)
This study is testing if an AI program can help doctors better spot heart transplant rejection by looking at echocardiograms and ECGs from patients who have had a heart transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06178744 on ClinicalTrials.gov |
What this trial studies
This research aims to improve the detection of cardiac transplant rejection by utilizing an Artificial Intelligence (AI) algorithm that analyzes data from electrocardiograms (ECGs) and echocardiograms. The study will observe patients undergoing endomyocardial biopsy after cardiac transplant to assess the accuracy of the AI in distinguishing between rejection and non-rejection episodes. By leveraging advanced technology, the study seeks to enhance diagnostic capabilities in post-transplant care.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have recently undergone a cardiac transplant and are scheduled for endomyocardial biopsy.
Not a fit: Patients who refuse to participate in the study will not benefit from the findings.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and timely detection of cardiac transplant rejection, improving patient outcomes.
How similar studies have performed: While the use of AI in medical diagnostics is a growing field, this specific application in cardiac transplant rejection detection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Atta Behfar, MD, PhD — Mayo Clinic
- Study coordinator: Ellie Thein
- Email: Thein.Ellie@mayo.edu
- Phone: 507-266-6519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.