RecruitingNot Applicable

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

Italy30 participantsStarted 2023-12-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine the utility of multiparametric CMR in identifying acute graft rejection in paediatric heart transplant recipients

Timeframe: 1 year

Trial details

NCT IDNCT06795958

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-06-30

Contact for this trial

Valentina Gesuete, MD

0390512149096 valentina.gesuete@aosp.bo.it

View on ClinicalTrials.gov More Pediatric Heart Transplant trials