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临床试验/NCT02727725
NCT02727725已完成不适用

Establishing the Clinical Usefulness Of Dark Blood Late Gadolinium Enhancement Images For The Detection Of Small Subendocardial Left Ventricular Infarcts - An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Sensitivity of the TRAMINER sequence in detecting myocardial fibrosis or acute infarction compared to the gold standard sequence will be measured.

研究概览

简要总结

  • The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization Transfer and Inversion Recovery) sequence provides at least as good visualization and detection of sub-endocardial scarring, fibrosis, and acute infarction as the current gold standard Inversion Recovery (IR) Turbo-Flash sequence.
  • The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in detecting small sub-endocardial scarring than the inversion recovery segmented gradient echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the accepted current gold standard for the detection of myocardial viability.

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

入选标准

  • Adults ≥18 years of age referred for a cardiac MRI with Gadolinium enhancement only at Advocate Lutheran General Hospital

排除标准

  • <18 years old,
  • Adults unable to consent
  • Adults for whom the MRI has not been previously scheduled
  • Adults with an order for any MRI other than cardiac MRI with Gadolinium enhancement

研究组 & 干预措施

Traminer MRI Sequence

Experimental

The TRAMINER MRI sequence implementation to be tested allows the acquisition of high resolution MR images in the free-breathing patient, by combining multiple averages and motion correction with the TRAMINER preparation.

干预措施: Traminer MRI Sequence (Other)

结局指标

主要结局

Sensitivity of the TRAMINER sequence in detecting myocardial fibrosis or acute infarction compared to the gold standard sequence will be measured.

时间窗: 6-12 months

The method of assessment is through a score using the 17 segment model of myocardial map.

次要结局

  • Reduction in clinical Magnetic Resonance (MRI) procedure time.(6-12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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