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Trial record 42 of 95 for:    gadobenate dimeglumine

Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging (DRAGON)

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ClinicalTrials.gov Identifier: NCT02400840
Recruitment Status : Withdrawn (Study is not feasable yet, due to evolution in the patients' care)
First Posted : March 27, 2015
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiac Graft Procedure: cardiac MRI Drug: gadobenic acid intravenous injection 0.2 ml/kg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Heart graft rejection
Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
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

Active Comparator: No rejection
Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
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




Primary Outcome Measures :
  1. Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Extracellular volume as measured by Cardiac MRI [ Time Frame: Day 1 ]
  2. T1 as measured by Cardiac MRI [ Time Frame: Day 1 ]
  3. T2 as measured by Cardiac MRI [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400840


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Arnaud GAY, MD Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02400840     History of Changes
Other Study ID Numbers: 2013/153/HP
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016