Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods

Study Overview
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Brief Summary
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The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.

Detailed Description
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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.

Official Title
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Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics

Conditions
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Angina Pectoris, Left Ventricular Wall Motion Abnormalities

Intervention / Treatment
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* Device: Cardiac ultrasound
* Device: MRI scanner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MRI-Arm<br>Myocardial vitality determination based on MRI diagnostics. | Device: MRI scanner<br>* 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.<br>|
| Experimental: Echo-Arm<br>Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis. | Device: Cardiac ultrasound<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State of health score | 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. | 6 month after diagnistics | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function (ejection function) | Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics. | 6 month after diagnistics | 
| End-diastolic and end-systolic volume. | End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics | 6 month after diagnostics | 
| Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE) | 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 | 18 month after diagnostics | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary stenosis, Angina pectoris, Left ventricular wall motion abnormalities, 2D-Strain