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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06178744
Status
Recruiting
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Conditions

  • Cardiac Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

Start date
Apr 4, 2024
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Ellie Thein
[email protected]
(507) 266-6519
Atta Behfar, MD, PhD
[email protected]
507-266-0318
Atta Behfar, MD, PhD (PRINCIPAL_INVESTIGATOR)

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