ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Myocardial Deformation Imaging

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.
ClinicalTrials.gov Identifier: NCT00476320
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : May 22, 2007
Sponsor:
Information provided by:
RWTH Aachen University

Brief Summary:

Myocardial deformation imaging allows analysis of myocardial viability in ischemic left ventricular dysfunction. This study will evaluate the predictive value of myocardial deformation imaging for improvement in cardiac function after revascularization therapy in comparison to contrast-enhanced cardiac magnetic resonance imaging (ceMRI).

In 55 patients with ischemic left ventricular dysfunction, myocardial viability was assessed using pixel-tracking-derived myocardial deformation imaging and ceMRI to predict recovery of function at 9±2 months follow-up. For each left ventricular segment in a 16-segment model peak systolic radial strain will be determined from parasternal 2D echocardiographic views and the amount of late hyperenhancement (LE) and maximal thickness of myocardial tissue without LE using ceMRI. The hypothesis is that compared with segments showing functional improvement, those that failed to recover had lower radial strain and lower thickness without LE and higher LE.


Condition or disease Intervention/treatment
Myocardial Viability in Ischemic Left Ventricular Dysfunction Prediction for Improvement in Cardiac Function After Revascularization Therapy Procedure: Magnetic Resonance Imaging Procedure: Revascularization Procedure: Echocardiography with myocardial deformation imaging

Detailed Description:

Between August 2004 and June 2006 195 patients with ischemic left ventricular dysfunction underwent MRI for the definition of myocardial viability. Onehundred-ten patients with non-ischemic cardiomyopathy or acute coronary syndromes were excluded from the study to avoid possible acute ischemia or stunning. Within the 85 patients with chronic ischemic heart disease, six patients refused participation in this study and five patients had echocardiographic windows insufficient for participation. Within the remaining 74 patients 55 patients underwent revascularization and 19 had no revascularization. These 55 patients form our study group! Functional recovery will be assessed using echocardiographic images before and 9±2 months after revascularization with a Vivid Seven System (GE Vingmed, Horton, Norway). Parasternal long-axis and short-axis views at basal, midventricular and apical levels, as well as 3 standard apical views (4 chamber, 2 chamber, and long axis) have been acquired (frame rate 56 to 92 frames/s). Segmental wall motion will be determined using the following score: 1=normokinetic, 1.5= mildly hypokinetic, 2= moderately or severely hypokinetic, 3= akinetic, or 4= dyskinetic. A segment is considered to demonstrate functional improvement during follow-up if it improved by at least 1 grade. Global functional recovery was considered in case of an increase in ejection fraction>5% at follow-up.

The three acquired parasternal short axis views will be analysed with the aid of a dedicated software package (EchoPAC BT 05.2, GE Vingmed, Horton, Norway). This system allows analysis of peak systolic circumferential and radial strain from short axis views based on detection of natural acoustic markers. The system calculates mean strain values for whole predefined LV segments, including all myocardial layers from the endocardium to epicardium.

All patients underwent cMRI within a few hours of the baseline echocardiographic study on a 1.5-T whole-body MR scanner (Intera, Best, Philips, the Netherlands). The assignment to a hyperenhancement category reflects the extent of hyperenhancement within each segment by visual assessment considering a 5-group scale: 0% hyperenhancement (group 1), 1 to 25% hyperenhancement (group 2), 26 to 50% hyperenhancement (group 3), 51 to 75% hyperenhancement (group 4) and 76 to 100% hyperenhancement (group 5).

In addition, the maximal thickness of myocardial tissue without late hyperenhancement will be determined for each LV segment. This is considered to be a parameter of the remaining viable myocardium.


Study Type : Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: The Use of Myocardial Deformation Imaging Based on Ultrasonic Pixel Tracking to Identify Reversible Myocardial Dysfunction
Study Start Date : August 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources





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 to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ischemic left ventricular dysfunction scheduled for coronary revascularization

Exclusion Criteria:

  • Patients with acute coronary syndrome and poor echocardiographic windows

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 ClinicalTrials.gov identifier (NCT number): NCT00476320


Locations
Germany
RWTH University Hospital
Aachen, Germany, 52057
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Becker, PhD, MD RWTH Aachen University Hospital
Study Chair: Rainer Hoffmann, Professor RWTH Aachen University Hospital
Study Director: Malte Kelm, Professor RWTH Aachen University Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00476320     History of Changes
Other Study ID Numbers: Becker-LE-FU-2007
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: May 22, 2007
Last Verified: May 2007

Keywords provided by RWTH Aachen University:
echocardiography
myocardial infarction
magnetic resonance imaging
revascularization
viability

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases