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Non-invasive Prediction of EArly Cardiac rEjection

Recruitingn/aAges 6 Years - 25 YearsAllVanderbilt University Medical Center
NCT07770659 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently in the first year post transplant and then every 1-2 years thereafter; these biopsies are associated with complications, can cause significant anxiety in patients and family members, and are a significant cost for the healthcare system. This project will evaluate non-invasive methods of detecting rejection using cardiac magnetic resonance imaging and blood testing with a goal to reduce the required number of cardiac catheterizations.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Received heart transplant at age \< 21 years old * \> 2 months from transplant * ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR) * CMR can be scheduled within 5 days from heart biopsy\* * Heart catheterization with biopsy is scheduled "for cause" to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance Exclusion Criteria: * No endomyocardial biopsy scheduled * Other illness or disease process that could potentially lead to myocardial edema or fibrosis * Contraindication to CMR with contrast * Previously enrolled in this study, UNLESS previous enrollment was heart biopsy scheduled for surveillance with no suspicion of AR AND final study status was documented as "no AR" AND current enrollment is heart biopsy is scheduled "for cause" to confirm suspected AR * Multiple transplanted organs * Requires anesthesia for CMR
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What it tests

  • Not listed
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Where

22 sites
Arkansas Children's Hospital
Little Rock, United States
Children's Hospital of Los Angeles
Los Angeles, United States
UCLA
Los Angeles, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, United States
Rady Children's Hospital
San Diego, United States
Children's Hospital Colorado
Denver, United States
University of Florida
Gainesville, United States
Joe DiMaggio Children's Hospital
Hollywood, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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