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NCT Number: NCT06178744

A Study of AI in Cardiac Transplant in 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).

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Key information

Conditions

Cardiac Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Lokensgard

CONTACT

[email protected]

507-422-5123

Atta Behfar, MD, PhD

CONTACT

[email protected]

507-266-0318

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: ORACLE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 21, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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