Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods
|ClinicalTrials.gov Identifier: NCT01389674|
Recruitment Status : Withdrawn
First Posted : July 8, 2011
Last Update Posted : June 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Angina Pectoris Left Ventricular Wall Motion Abnormalities||Procedure: 2D-strain echo||Not Applicable|
After myocard vitality diagnostics with MRI patients will underwent additionally an stress echocardiography within the exploration. By this ultrasound we will measure the LV mass and the ejection fraction per apical 2-, 3- and 4-chamber view.
In addition a 2D-strain-analysis will be done to measure the systolic and diastolic strain and also the circumferential and radial strain rate parameter (by depicting three parasternal short axis views in the basal, mid-ventricular and apical plane).
These measurements will be compared with the studies-conditioned MRI-finding (as reference) to find the optimal strain-parameter and the optimal cut-off-data for an intraprocedural vitality diagnostics of the single layers (endocardial, myocardial, and epicardial) for this patient group.
The data upraised through this are compared off-line to the MRI findings.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: 2D-strain echo
After myocard vitality diagnostics with MRI follows a stress echocardiography to determine the LV volumes and EF. The received Data are compare with the MRI-Data(reference)to identify the ideal strain-parameters and Cut-Off-Result for an intraprocedural vitality diagnostic of the different films (endocardial, myocardial and epicardial).
Procedure: 2D-strain echo
2D-strain-analysis with elevation of the radial and circumferential strain and strain rate parameter(systolic and diastolic)occurs through the echocardiography.
Comparison of the echocardiography and the MRI-vitality data, calculation of a cut out of vision value of a vitality diagnosis with the help of 2D-strain-analysis.
- Cut-Off-Value of vital myocardial tissue [ Time Frame: time during hospitalization ]It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.
- feasibility and safety of echocardiography during catheter investigations [ Time Frame: time during hospitalization and 1 months afterwards ]it will be analyzed if it is logistically possible to perform echo-test during the actual catheter investigations (feasibility) and if the patient will be exposed to any safety risk for logistic or sterility reasons.
- Determination of Strain-Parameter for identification of vital myocardial tissue [ Time Frame: time during hospitalization ]It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389674
|University Hospital Aachen|
|Aachen, Germany, 52074|
|Principal Investigator:||Michael Becker, MD||RWTH Aachen University|