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).
Conditions:
🦠 Cardiac Transplant Rejection
🗓️ Study Start (Actual) 4 April 2024
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 December 2023
  • First Submitted that Met QC Criteria 12 December 2023
  • First Posted 21 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 May 2024
  • Last Update Posted 21 May 2024
  • Last Verified May 2024