Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
研究概览
详细说明
Each patient with typical angina pectoris symptoms will get echocardiographic examination during the inclusion phase. If motion disorder of regional left ventricular myocardial wall is detected, patient will get coronary angiography (not study related, caused of typical angina pectoris symptoms and high probability of CHD). If coronary stenosis related to motion disorder is available, patient will be randomized in two groups during coronary angiography.
- First Group: Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of this echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI (Percutaneous Coronary Intervention) will be performed.
- Second Group: Coronary angiography by patient will be canceled. Patients will get viability assessment using MRI(Magnetic resonance imaging) within the next 7 days. When vitality will be established with MRI, patient will get PCI (Percutaneous Coronary Intervention).
In addition, as part of a feasibility analysis, the possibility of a consolidation of data of coronary angiography with the ultrasound images will be researched by first group of patients. The aim is to simplify the visualization of the intraprocedural vitality detection. For this purpose, a position sensor based on electromagnetic fields (EMT) will be used during coronary angiography.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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NRW
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Aachen、NRW、德国、52074
- University Hospital Aachen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Typical angina pectoris symptoms
- Echocardiographic determination of regional motion disfunction of left ventricular wall
- Establishment of needly treatment of stenosis related to motion disorder based on coronar angiography.
- Feasibility of MRI-Examination.
- Patients which are legally competent and which are mentally able to understand the study staff
- Patients give their written consent
Exclusion Criteria:
- Allergy against contrast agent
- Patients with limited renal function(GFR < 60 ml/min)
- Acute or instable angina pectoris
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：MRI-Arm
Myocardial vitality determination based on MRI diagnostics.
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Coronary angiography on patient will be canceled.
Patients will get viability assessment using MRI within the next 7 days.
When vitality will be established with MRI, patient will get PCI.
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实验性的：Echo-Arm
Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
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Patient will get echocardiographic examination during coronary angiography.
2D-Strain Analysis will be performed based on data of these echocardiographic examination.
Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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State of health score
大体时间：6 month after diagnistics
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State of health score will be determinated by all patients for the evaluation of clinical outcomes (using the standardized questionnaire on state of health (SF-36))6 months after clinical diagnostics.
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6 month after diagnistics
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Left ventricular function (ejection function)
大体时间：6 month after diagnistics
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Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
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6 month after diagnistics
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End-diastolic and end-systolic volume.
大体时间：6 month after diagnostics
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End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
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6 month after diagnostics
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Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
大体时间：18 month after diagnostics
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It will be determined, whether all patients suffered any major adverse cardiac and cerebrovascular events (MACCE) inter alia stroke, myocardial infarction, death 18 month after diagnostics
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18 month after diagnostics
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合作者和调查者
调查人员
- 首席研究员：Michael Becker, MD、University Hospital, Aachen
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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
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