Cardiac GraftDRAGONNCT02400840
Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
A study testing cardiac MRI and gadobenic acid intravenous injection 0.2 ml/kg in people with Cardiac Graft, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Graft
- What is being tested?
- cardiac MRI and gadobenic acid intravenous injection 0.2 ml/kg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- cardiac MRI, gadobenic acid intravenous injection 0.2 ml/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac MRIProcedure or surgery
Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
gadobenic acid intravenous injection 0.2 ml/kgDrug
gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
| Study group | Role | What they receive |
|---|---|---|
| Heart graft rejection | Experimental | Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time Receives: Procedure: cardiac MRI; Drug: gadobenic acid intravenous injection 0.2 ml/kg |
| No rejection | Active comparator | Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time Receives: Procedure: cardiac MRI; Drug: gadobenic acid intravenous injection 0.2 ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation
Measured: Day 1
Secondary outcomes (3)
Extracellular volume as measured by Cardiac MRI
Measured: Day 1
T1 as measured by Cardiac MRI
Measured: Day 1
T2 as measured by Cardiac MRI
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Study is not feasable yet, due to evolution in the patients' care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac GraftStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud GAY, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400840
- Sponsor's protocol ID
- 2013/153/HP
- Acronym
- DRAGON
- Status last verified
- May 2016
- First submitted
- 26 Jan 2015
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02400840
- Acronym / sponsor ID
- DRAGON / 2013/153/HP
- Conditions
- Cardiac Graft
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is not feasable yet, due to evolution in the patients' care
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart graft rejection | Experimental | Procedure: cardiac MRI, Drug: gadobenic acid intravenous injection 0.2 ml/kgAssessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time |
| No rejection | Active comparator | Procedure: cardiac MRI, Drug: gadobenic acid intravenous injection 0.2 ml/kgAssessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac MRICardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time | Procedure or surgery | Heart graft rejection, No rejection |
| gadobenic acid intravenous injection 0.2 ml/kggadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment | Drug | Heart graft rejection, No rejection |
Primary outcome
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation
Time frame: Day 1
3 secondary outcomes
Extracellular volume as measured by Cardiac MRI
Time frame: Day 1
T1 as measured by Cardiac MRI
Time frame: Day 1
T2 as measured by Cardiac MRI
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud GAY, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac MRI and gadobenic acid intravenous injection 0.2 ml/kg in people with Cardiac Graft, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.