Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- State of health score
研究概览
简要总结
The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Allergy against contrast agent
- •Patients with limited renal function(GFR < 60 ml/min)
- •Acute or instable angina pectoris
结局指标
主要结局
State of health score
时间窗: 6 month after diagnistics
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.
次要结局
- Left ventricular function (ejection function)(6 month after diagnistics)
- Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)(18 month after diagnostics)
- End-diastolic and end-systolic volume.(6 month after diagnostics)