Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2
- Conditions
- Heart TransplantationAcute Graft Rejection
- Interventions
- Device: MRI T2 quantification
- Registration Number
- NCT02261870
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALL_patients MRI T2 quantification MRI T2 quantification : heart transplant patients will have 4-6 MRI exams for T2 quantification during their first year after transplantation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (10)
CHU Grenoble
🇫🇷La Tronche, France
CHU de Nantes
🇫🇷Nantes, France
CHRU Nancy Brabois
🇫🇷Nancy, 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
Hospices Civils de Lyon
🇫🇷Bron, France