Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

Not Applicable

Withdrawn

• Conditions: Cardiac Graft
• Interventions: Procedure: cardiac MRI; Drug: gadobenic acid intravenous injection 0.2 ml/kg

• Registration Number: NCT02400840
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26
• Primary Completion: 2018-01
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No rejection	gadobenic acid intravenous injection 0.2 ml/kg	Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
Heart graft rejection	cardiac MRI	Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
Heart graft rejection	gadobenic acid intravenous injection 0.2 ml/kg	Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
No rejection	cardiac MRI	Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time

Primary Outcome Measures

Name	Time	Method
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation	Day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France