Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

Detailed Description
-----------------
Acute heart allograft rejection is a common complication after orthotopic heart transplantation. It can lead to multiple cardiac injuries and sometimes to patient's death. Currently, acute heart graft rejection screening is based on invasive strategies. Gold standard is represented by endomyocardial biopsies which provide side effects risk, rare but potentially fatal for the recipient. Cardiac MRI is an imaging tool recently used in cardiology. It is a non-invasive without any X-Ray exposition method well adapted to assess cardiac function and cardiac muscle composition. Cardiac MRI is probably a great tool to help the screening of acute heart allograft rejection, by detecting changes in myocardium structure. MRI validation as a screening tool for heart allograft rejection detection could help to reduce endomyocardial biopsies realised after orthotopic heart transplantation.

Official Title
-----------------
Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

Conditions
-----------------
Cardiac Graft

Intervention / Treatment
-----------------
* Procedure: cardiac MRI
* Drug: gadobenic acid intravenous injection 0.2 ml/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthotopic heart transplantation patients Endomyocardial biopsies < 72h Estimated glomerular filtration ratio >30ml/min (calculated by Cockcroft formula for patients age < 65 yo or MDRD for patients age >65 ans) Patients affiliated to French national health insurance For pre-menopausal female patients, negative pregnancy test Patient's consent form signature Patient with correct French writing and speaking comprehension Exclusion Criteria: Endomyocardial biopsies showing acute cellular rejection grade 1R or antibodies mediated rejection pAMR1 Patient in need of renal dialysis Past history of allergic reaction or side effects after gadolinium infusion Hemodynamical instability MRI contra-indication (claustrophobia, ocular metallic objects, non MRI compatible cardiac device, neurological non RMI compatible device, osteosynthesis prosthesis older than 1980) Pregnant or breast feeding woman Patient participating to another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart graft rejection<br>Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time | Procedure: cardiac MRI<br>* Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time<br>Drug: gadobenic acid intravenous injection 0.2 ml/kg<br>* gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment<br>|
| Active Comparator: No rejection<br>Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time | Procedure: cardiac MRI<br>* Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time<br>Drug: gadobenic acid intravenous injection 0.2 ml/kg<br>* gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular volume as measured by Cardiac MRI |  | Day 1 | 
| T1 as measured by Cardiac MRI |  | Day 1 | 
| T2 as measured by Cardiac MRI |  | Day 1 |