Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection
Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation
研究概览
详细说明
Objectives To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.
Background Detection of cardiac rejection is a major problem in cardiac transplantation. Invasive screenings at predefined time intervals for cellular rejection with using endomyocardial biopsies are standard procedures. However, cardiac biopsies are distressing and risky and are also costly. Moreover, as the histological expression of allograft rejection is patchy, endomyocardial biopsies may lead to sampling error. Thus, as the sensitivity is low and variable (range for 40 to 95%), indication of biopsy is still of debate.
Materials and methods All patients who undergone cardiac transplant are potentially eligible. They will be prospectively included in the study. They will have both examinations, their routine endomyocardial biopsies and cardiac MRI. Histological diagnosis of cellular rejection is given by the BILLINGHAM classification which is used in daily practice. Diagnosis of rejection of cardiac MRI is defined by the association of hyperintensity on T2-weighted sequence, and on gadolinium-enhanced sequences including SSFP (study state free precession) and myocardial delayed enhancement. Both MRI parameters attest of the presence of myocardial oedema related to acute rejection. Myocardial oedema is also associated with segmental abnormalities of myocardial contraction which is assessed by both CMR-tagged sequence.
Written informed consent will be required from the patients. Institutional review board approval will also be required.
Expected results and clinical implications We expect to demonstrate that CMRI is effective for detection of cellular rejection with a high sensitivity (expected sensitivity>95%) as compared to cardiac biopsy. In that condition, cardiac MRI could replace the invasive biopsy for serial detection and follow-up of rejection in heart transplant.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Paris、法国、75015
- Hopital Necker
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- all patients who had undergone cardiac transplants are eligible
Exclusion Criteria:
- no consent
- allergy to contrast agent (Gadolinium)
- severe renal failure (clearance < 30ml/min/1.73m²)
- claustrophobia
- severe arrhythmias
- absence of medical care insurance
- pregnancy
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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CARDIAC MRI
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To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The sensitivity and specificity of cardiac MRI for detecting heart transplant rejection will be calculated. The expected sensitivity and specificity are > 95%.
大体时间:24 MONTHS
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24 MONTHS
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合作者和调查者
调查人员
- 首席研究员:Ou Phalla, MCU PH、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- P081113
- 2009-A00985-52 (注册表标识符:ID RCB)
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