Acute Graft RejectionDRAGETNCT02261870
Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2
A study testing MRI T2 quantification in people with Acute Graft Rejection and Heart Transplantation, run by Central Hospital, Nancy, France at 10 sites in France.
Trial summary
The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Rejection, Heart Transplantation
- What is being tested?
- MRI T2 quantification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 10 sitesFrance
- Study dates
- 18 Feb 2015to 27 Feb 2020
- 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
- Heart transplant patient
- Able to realize 4 couples Biopsy/MRI within 12 months after the transplant
- Mandatory enrolment in a social security plan
- Patient having signed an informed consent.
Who cannot join
- Contraindication to MRI: pacemaker, ferromagnetic foreign body, etc
- Impossibility to undergo MRI: claustrophobia, morbid obesity, hospitalisation in intensive care unit, arrhythmia
- Pregnancy
- Patients under a measure of legal protection
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hospices Civils de Lyon
Bron, 69677
CHU Grenoble
La Tronche, 38700
CHRU Nancy Brabois
Nancy
CHU de Nantes
Nantes, 44093
Hôpital Européen Georges Pompidou
Paris, 75015
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75651
CHU Bordeaux
Pessac, 33604
CHU de Rennes
Rennes, 35033
Hopitaux Universitaires de Strasbourg
Strasbourg
CHU de Tours
Tours, 37044
About this study
Official title: "Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures
The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification.
Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.
- Conditions
- Acute Graft Rejection, Heart Transplantation
- Being tested
- MRI T2 quantification
- Keywords
- MRI, T2 quantification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI T2 quantificationDevice
MRI acquisitions will be performed according to the already described method based on conventional Fast Spin Echo sequences and with an additional calibration pad positioned on the patient thorax (dedicated pad made by the Nancy CIC-IT with stable and adapted T2). MRI will be performed if possible before the biopsy and otherwise the radiologist will be kept blinded of the biopsy results.
| Study group | Role | What they receive |
|---|---|---|
| ALL_patients | Experimental | MRI T2 quantification : heart transplant patients will have 4-6 MRI exams for T2 quantification during their first year after transplantation. Receives: Device: MRI T2 quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval).
endpoint = sensitivity and specificity acute rejection means presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R)
Measured: 3 years after first inclusion
Secondary outcomes (5)
Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R).
endpoint = number of rejections For this purpose, rejection will be defined as: a) acute rejection documented by presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R), or b) marked decrease in left ventricle ejection fraction (>10%), reversible after subsequent increase in immunosuppressive treatment.
Measured: 3 years after first inclusion
Complications with MRI and with biopsies.
endpoint = Number of adverse events due to both exams
Measured: 3 years after first inclusion
Magnitude of better tolerability of MRI over biopsies for the patient.
endpoint = Physical and psychological distress assessed by questionnaire using Likert scales. This questionnaire will be completed by the patients.
Measured: 3 years after first inclusion
Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies.
endpoint = 95% interobserver limit of agreement for T2 quantification and Cohen's Kappa coefficient for histological grading.
Measured: 3 years after first inclusion
Level of confidence, at the end of the study, of the expert-physicians of each centre concerning the use of T2 quantification as an alternative to routine biopsies.
endpoint = Confidence assessed by questionnaire using Likert scales. This questionnaire will be completed by study investigators at the end of the study.
Measured: 3 years after first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start18 Feb 2015
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Graft RejectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Bonnemains, MD, PhD, Principal investigator, INSERM, IADI U47, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261870
- Sponsor's protocol ID
- 2014-A00848-39
- Other IDs
- CIC1433
- Acronym
- DRAGET
- Status last verified
- May 2020
- First submitted
- 25 Sep 2014
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonnemains L, Cherifi A, Girerd N, Odille F, Felblinger J. Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2 quantification with MRI in comparison to myocardial biopsies. BMJ Open. 2015 Oct 29;5(10):e008963. doi: 10.1136/bmjopen-2015-008963.
PubMed 26515686
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures
- ClinicalTrials.gov ID
- NCT02261870
- Acronym / sponsor ID
- DRAGET / 2014-A00848-39
- Conditions
- Acute Graft Rejection, Heart Transplantation
- Keywords
- MRI, T2 quantification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 10 Oct 2014 (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.
The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification.
Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL_patients | Experimental | Device: MRI T2 quantificationMRI T2 quantification : heart transplant patients will have 4-6 MRI exams for T2 quantification during their first year after transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart transplant patient
- Able to realize 4 couples Biopsy/MRI within 12 months after the transplant
- Mandatory enrolment in a social security plan
- Patient having signed an informed consent.
Key exclusion criteria (4 listed)
- Contraindication to MRI: pacemaker, ferromagnetic foreign body, etc
- Impossibility to undergo MRI: claustrophobia, morbid obesity, hospitalisation in intensive care unit, arrhythmia
- Pregnancy
- Patients under a measure of legal protection
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 |
|---|---|---|
| MRI T2 quantificationMRI acquisitions will be performed according to the already described method based on conventional Fast Spin Echo sequences and with an additional calibration pad positioned on the patient thorax (dedicated pad made by the Nancy CIC-IT with stable and adapted T2). MRI will be performed if possible before the biopsy and otherwise the radiologist will be kept blinded of the biopsy results. | Device | ALL_patients |
Primary outcome
Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval).
Time frame: 3 years after first inclusion
endpoint = sensitivity and specificity acute rejection means presence of damaged myocytes in endomyocardial biopsy (former grade 2, grade 2R and grade 3R)
5 secondary outcomes
Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R).
Time frame: 3 years after first inclusion
Complications with MRI and with biopsies.
Time frame: 3 years after first inclusion
Magnitude of better tolerability of MRI over biopsies for the patient.
Time frame: 3 years after first inclusion
Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies.
Time frame: 3 years after first inclusion
Level of confidence, at the end of the study, of the expert-physicians of each centre concerning the use of T2 quantification as an alternative to routine biopsies.
Time frame: 3 years after first inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 26515686Bonnemains L, Cherifi A, Girerd N, Odille F, Felblinger J. Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2 quantification with MRI in comparison to myocardial biopsies. BMJ Open. 2015 Oct 29;5(10):e008963. doi: 10.1136/bmjopen-2015-008963.
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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.
Laurent Bonnemains, MD, PhD principal investigator
INSERM, IADI U47, Nancy, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI T2 quantification in people with Acute Graft Rejection and Heart Transplantation, run by Central Hospital, Nancy, France at 10 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval). (time frame: 3 years after first inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261870, which also lists 1 linked publication.
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 12 May 2020.