"Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 18
- 主要终点
- Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Sensitivity and specificity of myocardial T2 assessed with MRI for the diagnosis of histological heart graft rejection (with 95% confidence interval).
时间窗: 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)
次要结局
- Inter-observer reproducibility of T2 quantification with MRI and of pathological grading of the biopsies.(3 years after first inclusion)
- 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)
- 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)