Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation
研究概览
简要总结
Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.
详细描述
Acute heart allograft rejection is a common complication after orthotopic heart transplantation. It can lead to multiple cardiac injuries and sometimes to patient's death. Currently, acute heart graft rejection screening is based on invasive strategies. Gold standard is represented by endomyocardial biopsies which provide side effects risk, rare but potentially fatal for the recipient. Cardiac MRI is an imaging tool recently used in cardiology. It is a non-invasive without any X-Ray exposition method well adapted to assess cardiac function and cardiac muscle composition. Cardiac MRI is probably a great tool to help the screening of acute heart allograft rejection, by detecting changes in myocardium structure. MRI validation as a screening tool for heart allograft rejection detection could help to reduce endomyocardial biopsies realised after orthotopic heart transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •Orthotopic heart transplantation patients
- •Endomyocardial biopsies < 72h
- •Estimated glomerular filtration ratio >30ml/min (calculated by Cockcroft formula for patients age < 65 yo or MDRD for patients age >65 ans)
- •Patients affiliated to French national health insurance
- •For pre-menopausal female patients, negative pregnancy test
- •Patient's consent form signature
- •Patient with correct French writing and speaking comprehension
排除标准
- •Endomyocardial biopsies showing acute cellular rejection grade 1R or antibodies mediated rejection pAMR1
- •Patient in need of renal dialysis
- •Past history of allergic reaction or side effects after gadolinium infusion
- •Hemodynamical instability
- •MRI contra-indication (claustrophobia, ocular metallic objects, non MRI compatible cardiac device, neurological non RMI compatible device, osteosynthesis prosthesis older than 1980)
- •Pregnant or breast feeding woman
- •Patient participating to another clinical trial
研究组 & 干预措施
Heart graft rejection
Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
干预措施: cardiac MRI (Procedure)
Heart graft rejection
Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
干预措施: gadobenic acid intravenous injection 0.2 ml/kg (Drug)
No rejection
Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
干预措施: cardiac MRI (Procedure)
No rejection
Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time
干预措施: gadobenic acid intravenous injection 0.2 ml/kg (Drug)
结局指标
主要结局
Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation
时间窗: Day 1
次要结局
- Extracellular volume as measured by Cardiac MRI(Day 1)
- T1 as measured by Cardiac MRI(Day 1)
- T2 as measured by Cardiac MRI(Day 1)