Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
- Conditions
- Left Ventricular Wall Motion AbnormalitiesAngina Pectoris
- Interventions
- Device: MRI scannerDevice: Cardiac ultrasound
- Registration Number
- NCT01934699
- Lead Sponsor
- RWTH Aachen University
- Brief Summary
The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
- 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
- Allergy against contrast agent
- Patients with limited renal function(GFR < 60 ml/min)
- Acute or instable angina pectoris
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRI-Arm MRI scanner Myocardial vitality determination based on MRI diagnostics. Echo-Arm Cardiac ultrasound Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
- Primary Outcome Measures
Name Time Method State of health score 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.
- Secondary Outcome Measures
Name Time Method Left ventricular function (ejection function) 6 month after diagnistics Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE) 18 month after diagnostics 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
End-diastolic and end-systolic volume. 6 month after diagnostics End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
Trial Locations
- Locations (1)
University Hospital Aachen
🇩🇪Aachen, NRW, Germany