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

NCT ID: NCT06178744

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Cardiac Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Atta Behfar MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atta Behfar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ellie Thein

Role: CONTACT

507-266-6519

Atta Behfar, MD, PhD

Role: CONTACT

507-266-0318

Facility Contacts

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Ellie Thein

Role: primary

(507) 266-6519

Atta Behfar, MD, PhD

Role: backup

507-266-0318

Other Identifiers

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23-006378

Identifier Type: -

Identifier Source: org_study_id

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