Heart Transplant Rejection Clinical Trial
Official title:
Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation
To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant in childhood.
Objectives To find a non-invasive alternative (with using cardiac MRI) to invasive
endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart
transplant in childhood.
Background Detection of cardiac rejection is a major problem in cardiac transplantation.
Invasive screenings at predefined time intervals for cellular rejection with using
endomyocardial biopsies are standard procedures. However, cardiac biopsies are distressing
and risky and are also costly. Moreover, as the histological expression of allograft
rejection is patchy, endomyocardial biopsies may lead to sampling error. Thus, as the
sensitivity is low and variable (range for 40 to 95%), indication of biopsy is still of
debate.
Materials and methods All patients who undergone cardiac transplant are potentially
eligible. They will be prospectively included in the study. They will have both
examinations, their routine endomyocardial biopsies and cardiac MRI. Histological diagnosis
of cellular rejection is given by the BILLINGHAM classification which is used in daily
practice. Diagnosis of rejection of cardiac MRI is defined by the association of
hyperintensity on T2-weighted sequence, and on gadolinium-enhanced sequences including SSFP
(study state free precession) and myocardial delayed enhancement. Both MRI parameters attest
of the presence of myocardial oedema related to acute rejection. Myocardial oedema is also
associated with segmental abnormalities of myocardial contraction which is assessed by both
CMR-tagged sequence.
Written informed consent will be required from the patients. Institutional review board
approval will also be required.
Expected results and clinical implications We expect to demonstrate that CMRI is effective
for detection of cellular rejection with a high sensitivity (expected sensitivity>95%) as
compared to cardiac biopsy. In that condition, cardiac MRI could replace the invasive biopsy
for serial detection and follow-up of rejection in heart transplant.
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