Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2 (DRAGET)

Central Hospital, Nancy, France

Status: Completed

Conditions: Acute Graft Rejection; Heart Transplantation

Treatments: Device: MRI T2 quantification

Study type: Interventional

Funder types: Other

Identifiers

NCT02261870

2014-A00848-39

CIC1433 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

ALL_patients

Experimental group

Description:

MRI T2 quantification : heart transplant patients will have 4-6 MRI exams for T2 quantification during their first year after transplantation.

Treatment:

Device: MRI T2 quantification