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
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
- 否
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
研究点 (2)
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