Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

Cardiac Graft Clinical Trial

— DRAGON  

Official title:

Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02400840
• Other study ID #: 2013/153/HP
• Status: Withdrawn
• Phase: N/A
• First received: January 26, 2015
• Last updated: May 25, 2016
• Start date: January 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Cardiac Graft

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation		Day 1	No
Secondary	Extracellular volume as measured by Cardiac MRI		Day 1	No
Secondary	T1 as measured by Cardiac MRI		Day 1	No
Secondary	T2 as measured by Cardiac MRI		Day 1	No