Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389674
Recruitment Status : Withdrawn
First Posted : July 8, 2011
Last Update Posted : June 9, 2014
Information provided by (Responsible Party):
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
Angina Pectoris Left Ventricular Wall Motion Abnormalities Procedure: 2D-strain echo Not Applicable

Detailed Description:

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01389674

University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Principal Investigator: Michael Becker, MD RWTH Aachen University

Responsible Party: RWTH Aachen University Identifier: NCT01389674     History of Changes
Other Study ID Numbers: HIB-Study
CTC-A 08-001
EK 079/10
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: June 9, 2014
Last Verified: June 2014

Keywords provided by RWTH Aachen University:
coronary stenosis
Angina pectoris
left ventricular wall motion abnormalities

Additional relevant MeSH terms:
Congenital Abnormalities
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms