Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.
Left Ventricular Wall Motion Abnormalities
Device: Cardiac ultrasound
Device: MRI scanner
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics|
- State of health score [ Time Frame: 6 month after diagnistics ] [ Designated as safety issue: Yes ]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.
- Left ventricular function (ejection function) [ Time Frame: 6 month after diagnistics ] [ Designated as safety issue: Yes ]Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
- End-diastolic and end-systolic volume. [ Time Frame: 6 month after diagnostics ] [ Designated as safety issue: Yes ]End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
- Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE) [ Time Frame: 18 month after diagnostics ] [ Designated as safety issue: Yes ]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
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: MRI-Arm
Myocardial vitality determination based on MRI diagnostics.
Device: MRI scanner
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.
Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis.
Device: Cardiac ultrasound
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934699
|Contact: Michael Becker, MD||004924180 ext 80092|
|Contact: Margarita Gritzewskifirstname.lastname@example.org|
|University Hospital Aachen||Recruiting|
|Aachen, NRW, Germany, 52074|
|Contact: Margarita Gritzewski 004924180 ext 80092 email@example.com|
|Principal Investigator: Michael Becker, MD|
|Sub-Investigator: Mohammad Almalla, MD|
|Sub-Investigator: Ertunc Altiok, MD|
|Sub-Investigator: Alexander Schuh, MD|
|Principal Investigator:||Michael Becker, MD||University Hospital, Aachen|