Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
NCT ID: NCT02400840
Last Updated: 2016-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2015-01-31
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2
NCT02261870
Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection
NCT01136135
The GRAFT Study: Evaluation of Graft Function, Rejection and Cardiac Allograft Vasculopathy in First Heart Transplant Recipients.
NCT02077764
Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients
NCT06795958
Cardiac MRI and Cardiac Allograft Rejection
NCT04311346
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Heart graft rejection
Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
cardiac MRI
Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
gadobenic acid intravenous injection 0.2 ml/kg
gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
No rejection
Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
cardiac MRI
Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
gadobenic acid intravenous injection 0.2 ml/kg
gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cardiac MRI
Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
gadobenic acid intravenous injection 0.2 ml/kg
gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Rouen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arnaud GAY, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rouen University Hospital
Rouen, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013/153/HP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.