Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Graft
Intervention: cardiac MRI (Procedure); gadobenic acid intravenous injection 0.2 ml/kg (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Rouen Official(s) and/or principal investigator(s): Arnaud GAY, MD, Principal Investigator, Affiliation: Rouen University Hospital
Overall contact: Arnaud GAY, MD, Email: arnaud.gay@chu-rouen.fr
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.
Clinical Details
Official title: Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Primary outcome: Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation
Secondary outcome: Extracellular volume as measured by Cardiac MRIT1 as measured by Cardiac MRI T2 as measured by Cardiac MRI
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Arnaud GAY, MD, Email: arnaud.gay@chu-rouen.fr
Rouen University Hospital, Rouen 76031, France; Recruiting Arnaud GAY, MD, Email: arnaud.gay@chu-rouen.fr
Additional Information
Starting date: January 2015
Last updated: March 26, 2015
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