Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

This study is currently recruiting participants.
Verified May 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01389674
First received: February 3, 2009
Last updated: May 21, 2013
Last verified: May 2013

February 3, 2009
May 21, 2013
April 2010
December 2013   (final data collection date for primary outcome measure)
Cut-Off-Value of vital myocardial tissue [ Time Frame: time during hospitalization ] [ Designated as safety issue: Yes ]
It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.
feasibility and safety [ Time Frame: time during hospitalization and 1 months afterwards ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01389674 on ClinicalTrials.gov Archive Site
  • feasibility and safety of echocardiography during catheter investigations [ Time Frame: time during hospitalization and 1 months afterwards ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue
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Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods
Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy

The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Angina Pectoris
  • Left Ventricular Wall Motion Abnormalities
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.

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).
Intervention: Procedure: 2D-strain echo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • left ventricular wall motion abnormalities
  • existent myocardial vitality MRI exploration
  • reduced LV-function
  • steady angina pectoris
  • patients which are legally competent and which are mentally able to understand the study staff
  • patients give their written consent

Exclusion Criteria:

  • pregnancy or lactation
  • acute or instable angina pectoris
  • acute myocardial infraction in the last 3 month
Both
18 Years and older
No
Contact: Michael Becker, MD 004924180 ext 80092 mibecker@ukaachen.de
Germany
 
NCT01389674
HIB-Study, CTC-A 08-001, EK 079/10
No
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Michael Becker, MD RWTH Aachen University
RWTH Aachen University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP