Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
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|ClinicalTrials.gov Identifier: NCT01934699|
Recruitment Status : Unknown
Verified September 2015 by RWTH Aachen University.
Recruitment status was: Active, not recruiting
First Posted : September 4, 2013
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Angina Pectoris Left Ventricular Wall Motion Abnormalities||Device: Cardiac ultrasound Device: MRI scanner||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||July 2016|
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.
- State of health score [ Time Frame: 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.
- Left ventricular function (ejection function) [ Time Frame: 6 month after diagnistics ]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 ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934699
|University Hospital Aachen|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Michael Becker, MD||University Hospital, Aachen|