NCT02400840

Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Graft

Interventions

Type	Name	Description
PROCEDURE	cardiac MRI	Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
DRUG	gadobenic acid intravenous injection 0.2 ml/kg	gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-01-01
• Completion: 2018-05-01
• First posted: 2015-03-27
• Last updated: 2016-05-26

Locations

1 site across 1 country: France