Acute Graft Rejection, Heart Transplantation
Conditions
Keywords
MRI, T2 quantification
Brief summary
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.
Interventions
DEVICEMRI T2 quantification
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.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart transplant patient * Able to realize 4 couples Biopsy/MRI within 12 months after the transplant * Mandatory enrolment in a social security plan * Patient having signed an informed consent.
Exclusion criteria
* Contraindication to MRI: pacemaker, ferromagnetic foreign body, etc * Impossibility to undergo MRI: claustrophobia, morbid obesity, hospitalisation in intensive care unit, arrhythmia * Pregnancy * Patients under a measure of legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval). | 3 years after first inclusion | endpoint = sensitivity and specificity acute rejection means presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R). | 3 years after first inclusion | 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. |
| Complications with MRI and with biopsies. | 3 years after first inclusion | endpoint = Number of adverse events due to both exams |
| Magnitude of better tolerability of MRI over biopsies for the patient. | 3 years after first inclusion | endpoint = Physical and psychological distress assessed by questionnaire using Likert scales. This questionnaire will be completed by the patients. |
| Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies. | 3 years after first inclusion | endpoint = 95% interobserver limit of agreement for T2 quantification and Cohen's Kappa coefficient for histological grading. |
| 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. | 3 years after first inclusion | endpoint = Confidence assessed by questionnaire using Likert scales. This questionnaire will be completed by study investigators at the end of the study. |
Countries
France
Outcome results
None listed