The Use of Myocardial Deformation Imaging

May 21, 2007 updated by: RWTH Aachen University

The Use of Myocardial Deformation Imaging Based on Ultrasonic Pixel Tracking to Identify Reversible Myocardial Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52057
        • RWTH University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ischemic left ventricular dysfunction scheduled for coronary revascularization

Exclusion Criteria:

  • Patients with acute coronary syndrome and poor echocardiographic windows

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Estimate)

May 22, 2007

Last Update Submitted That Met QC Criteria

May 21, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Becker-LE-FU-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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