Detection of Acute Graft Rejection in Heart Transplant Patients by Estimation of T2

Heart Transplantation Clinical Trial

— DRAGET  

Official title:

"Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261870
• Other study ID #: 2014-A00848-39
• Secondary ID: CIC1433
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Graft Rejection
• Heart Transplantation

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