Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00208676
First received: September 13, 2005
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

There are many children that have heart dysfunction because they are either born with Congenital Heart Disease (CHD) or developed poor heart function because their hearts are ill. The invention of medical technology helps in the treatment of these children. New heart echocardiogram (echo) techniques including Tissue Doppler (TDI), Tissue Synchronization Imaging (TSI) and 3 dimensional echocardiography (3D) are imaging technologies that we hope will help in the diagnosis and treatment of these children.

Tissue Doppler Imaging is a noninvasive technique that measures the speed of heart muscle movement. Tissue Synchronization Imaging measures how well the lower pumping chambers of the heart are working together. A 3D echo is a 3 dimensional picture of a beating heart that allows your doctor to see the heart from any angle. These techniques are noninvasive, meaning on the outside of your body. The size and function of the ventricles (the lower part of the heart) can change under different conditions. Using these techniques we will attempt to better determine how well the ventricles function during illness and health.


Condition
Congenital Heart Defects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-Invasive Quantitation of Myocardial Dysfunction by Tissue Doppler / Synchronization Imaging in Children With Congenital Heart Defects (CHD)

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: January 2006
Detailed Description:

All subjects who are treated at Sibley Heart Center at Children's Healthcare of Atlanta with the diagnosis of a congenital heart defect or an acquired heart condition (i.e. heart failure) may be approached for possible participation into the study. These patients will include newly diagnosed patients as well as patients who were diagnosed in previous years and have received medical treatment for their defect or condition. The following describe study procedures:

Echocardiographic assessment Standard 2-dimensional, M-mode, and Doppler or 3-dimensional echocardiography evaluation will be performed. We will assess cardiac function using left ventricular shortening (SF) and ejection fractions (EF). The EF will be calculated using both M-Mode and by Simpson's rule. We will also perform tissue synchronization imaging (TSI) and tissue Doppler imaging (TDI) using the GE Vivid 7 echocardiographic system. Both TSI and TDI will assist investigators in assessing mechanical synchrony. The research echocardiograms will occur at the time of routine assessments.

Clinical assessment/data collection Clinical information from the chart will be collected for this study. The information will include the doctor's evaluation of general health, including diagnosis and the names of any medications the participant may be taking. If the child has undergone a routine MRI for the purpose of clinical care, the MRI measures will be collected in order to compare MRI images and measures to the new 3D echo technique. Finally, EKG data will be collected at each visit. EKGs are performed routinely for these patients however, if one is not performed, the study staff will perform an EKG assessment in order to have electromechanical information (i.e. arrhythmias) on all children participating.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any child up to 21 years of age with a congenital heart defect -

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208676

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Derek Fyfe, MD Emory University
  More Information

Publications:
Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208676     History of Changes
Other Study ID Numbers: 0807-2004
Study First Received: September 13, 2005
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
heart defects
pediatrics

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014