跳至主要内容
临床试验/NCT02834104
NCT02834104已完成不适用

Validation of Fibrosis Quantification Using T1 Mapping Against Histology as Reference and Comparison With Fibrosis Biomarkers

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
quantification of myocardial fibrosis by RMI

研究概览

简要总结

Myocardial fibrosis is recognized as the pathologic entity of extracellular matrix remodeling. Diffuse, reactive fibrosis is increasingly recognized in a variety of conditions despite the absence of ischemia. Regardless of the etiology, fibrosis leads to increased myocardial stiffness thereby promoting cardiac dysfunction. This dysfunction may present clinically with symptoms of cardiac failure although this is often a subclinical disease. Various imaging modalities and collagen biomarkers have been used as surrogate markers to assess the presence, extent, and turnover of myocardial fibrosis. Techniques using echocardiography, cardiac magnetic resonance, and nuclear imaging have been developed to detect early features of systolic and diastolic left ventricular dysfunction and impaired contractile reserve. Further identification of diffuse reactive fibrosis may be possible with evolving cardiac magnetic resonance and molecular techniques. The goal of this protocol is to validate cardiac magnetic resonance imaging as a new tool for fibrosis quantification against histology as standard of reference.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • All patients who require surgical aortic valve replacement , which will benefit from an MRI to measure fibrosis in the months preceding the surgery.
  • Patient submitted to the social security scheme
  • Patient agreeing to participate in the study and who signed the informed consent.

排除标准

  • A history of myocardial
  • Unstable Patients requiring treatment with catecholamines.
  • hepatocellular insufficiency of alcoholic origin
  • Severe renal impairment
  • Appearance before examining coronary syndrome at high risk, defined according to international recommendations.
  • History of known allergy to gadolinium at diagnosis
  • Pregnant or lactating
  • Patient < 18 years

结局指标

主要结局

quantification of myocardial fibrosis by RMI

时间窗: 5years

次要结局

  • measuring biomarkers of fibrosis(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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