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Clinical Trials in Italy / NCT06795958
Recruiting Observational

Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients

NCT06795958 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-12-12
Last updated
2025-01-28

Condition(s) studied

Pediatric Heart Transplant

Study summary

Acute cardiac rejection is currently diagnosed by endomyocardial biopsy (EMB), but multiparametric cardiac magnetic resonance (CMR) may be a non-invasive alternative by its capacity for myocardial structure and function characterization. Our primary aim was to determine the utility of multiparametric CMR in identifying acute graft rejection in paediatric heart transplant recipients. The second aim was to compare textural features of parametric maps in cases of rejection versus those without rejection.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * children and young adults (transplanted when they were ≤ 18 years) who undergo an EMB for routine surveillance without contraindications to contrast-enhanced CMR Exclusion Criteria: * We also don't recruit recipients who were \< 3 months post-heart transplantation to reduce the possibility of confounding from ischemia-reperfusion injury that occurs with the heart transplant procedure

Primary outcome measure(s)

  • To determine the utility of multiparametric CMR in identifying acute graft rejection in paediatric heart transplant recipients — 1 year
    CMR data were stratified according to the presence (grade ≥ 2) or absence (grade 0 or 1) of significant acute cellular rejection on EMB

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06795958 on ClinicalTrials.gov ↗ ← All trials in Italy