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Completed

NCT Number: NCT02261870

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

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.

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Key information

Conditions

Acute Graft Rejection Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon, Bron, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    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.

  2. Complications with MRI and with biopsies.

    Time frame: 3 years after first inclusion

    endpoint = Number of adverse events due to both exams

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

    Time frame: 3 years after first inclusion

    endpoint = Physical and psychological distress assessed by questionnaire using Likert scales. This questionnaire will be completed by the patients.

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

    Time frame: 3 years after first inclusion

    endpoint = 95% interobserver limit of agreement for T2 quantification and Cohen's Kappa coefficient for histological grading.

  5. 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

    endpoint = Confidence assessed by questionnaire using Likert scales. This questionnaire will be completed by study investigators at the end of the study.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: DRAGET

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2014
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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