Clinical trial NCT02261870: Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2
Official title: "Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Graft Rejection
Heart Transplantation
Keywords: MRI, T2 quantification
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval).
timeFrame: 3 years after first inclusion
Secondary outcomes:
measure: Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R).
timeFrame: 3 years after first inclusion
measure: Complications with MRI and with biopsies.
timeFrame: 3 years after first inclusion
measure: Magnitude of better tolerability of MRI over biopsies for the patient.
timeFrame: 3 years after first inclusion
measure: Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies.
timeFrame: 3 years after first inclusion
measure: 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.
timeFrame: 3 years after first inclusion
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
city: La Tronche
country: France
facility: CHU Grenoble
city: Nancy
country: France
facility: CHRU Nancy Brabois
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
city: Pessac
country: France
facility: CHU Bordeaux
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: INSERM, IADI U47, Nancy, France
name: Laurent Bonnemains, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnemains L, Cherifi A, Girerd N, Odille F, Felblinger J. Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2 quantification with MRI in comparison to myocardial biopsies. BMJ Open. 2015 Oct 29;5(10):e008963. doi: 10.1136/bmjopen-2015-008963.