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

NCT02261870 | Completed

• 2 other identifiers: 2014-A00848-39CIC1433
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Acute Graft Rejection; Heart Transplantation

Keywords

MRI, T2 quantification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of histological or clinical rejection within months of a couple MRI/biopsy with normal biopsy (grade<2R).

  3 years after first inclusion

• Complications with MRI and with biopsies.

  3 years after first inclusion

• Magnitude of better tolerability of MRI over biopsies for the patient.

  3 years after first inclusion

• Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies.

  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.

  3 years after first inclusion

Study Arms (1)

ALL_patients

EXPERIMENTAL

MRI T2 quantification : heart transplant patients will have 4-6 MRI exams for T2 quantification during their first year after transplantation.

Device: MRI T2 quantification

Interventions

MRI T2 quantification DEVICE

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.

ALL_patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (10)

Hospices Civils de Lyon

Bron, 69677, France

Location

CHU Grenoble

La Tronche, 38700, France

Location

CHRU Nancy Brabois

Nancy, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75651, France

Location

CHU Bordeaux

Pessac, 33604, France

Location

CHU de Rennes

Rennes, 35033, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, France

Location

CHU de Tours

Tours, 37044, France

Location

Related Publications (1)

• 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.

  PMID: 26515686 DERIVED

Study Officials

• Laurent Bonnemains, MD, PhD

  INSERM, IADI U47, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 10, 2014
• Study Start: February 18, 2015
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

FR (10)