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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02261870
Other study ID # 2014-A00848-39
Secondary ID CIC1433
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2015
Est. completion date February 27, 2020

Study information

Verified date May 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date February 27, 2020
Est. primary completion date February 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI T2 quantification
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.

Locations

Country Name City State
France Hospices Civils de Lyon Bron
France CHU Grenoble La Tronche
France CHRU Nancy Brabois Nancy
France CHU de Nantes Nantes
France Groupe Hospitalier Pitié-Salpêtrière Paris
France Hôpital Européen Georges Pompidou Paris
France CHU Bordeaux Pessac
France CHU de Rennes Rennes
France Hopitaux Universitaires de Strasbourg Strasbourg
France CHU de Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 3 years after first inclusion
Secondary 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. 3 years after first inclusion
Secondary Complications with MRI and with biopsies. endpoint = Number of adverse events due to both exams 3 years after first inclusion
Secondary 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. 3 years after first inclusion
Secondary 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. 3 years after first inclusion
Secondary 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. 3 years after first inclusion
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