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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 MRI

T1 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

Page last updated: August 23, 2015

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