Cardiac Graft
Conditions
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.
Interventions
PROCEDUREcardiac MRI
Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
DRUGgadobenic acid intravenous injection 0.2 ml/kg
gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
Sponsors
University Hospital, Rouen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation | Day 1 |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed