The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification. Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
116
MRI acquisitions will be performed according to the already described method based on conventional Fast Spin Echo sequences and with an additional calibration pad positioned on the patient thorax (dedicated pad made by the Nancy CIC-IT with stable and adapted T2). MRI will be performed if possible before the biopsy and otherwise the radiologist will be kept blinded of the biopsy results.
Hospices Civils de Lyon
Bron, France
CHU Grenoble
La Tronche, France
CHRU Nancy Brabois
Nancy, France
CHU de Nantes
Nantes, France
Hôpital Européen Georges Pompidou
Paris, France
Groupe Hospitalier Pitié-Salpêtrière
Paris, France
CHU Bordeaux
Pessac, France
CHU de Rennes
Rennes, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
CHU de Tours
Tours, France
Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval).
endpoint = sensitivity and specificity acute rejection means presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R)
Time frame: 3 years after first inclusion
Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R).
endpoint = number of rejections For this purpose, rejection will be defined as: a) acute rejection documented by presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R), or b) marked decrease in left ventricle ejection fraction (\>10%), reversible after subsequent increase in immunosuppressive treatment.
Time frame: 3 years after first inclusion
Complications with MRI and with biopsies.
endpoint = Number of adverse events due to both exams
Time frame: 3 years after first inclusion
Magnitude of better tolerability of MRI over biopsies for the patient.
endpoint = Physical and psychological distress assessed by questionnaire using Likert scales. This questionnaire will be completed by the patients.
Time frame: 3 years after first inclusion
Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies.
endpoint = 95% interobserver limit of agreement for T2 quantification and Cohen's Kappa coefficient for histological grading.
Time frame: 3 years after first inclusion
Level of confidence, at the end of the study, of the expert-physicians of each centre concerning the use of T2 quantification as an alternative to routine biopsies.
endpoint = Confidence assessed by questionnaire using Likert scales. This questionnaire will be completed by study investigators at the end of the study.
Time frame: 3 years after first inclusion
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