Clinical trial NCT02400840: Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
Official title: Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Graft
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation
timeFrame: Day 1
Secondary outcomes:
measure: Extracellular volume as measured by Cardiac MRI
timeFrame: Day 1
measure: T1 as measured by Cardiac MRI
timeFrame: Day 1
measure: T2 as measured by Cardiac MRI
timeFrame: Day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Arnaud GAY, MD
role: PRINCIPAL_INVESTIGATOR
References: