Speckle Tracking in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00489957
First received: June 20, 2007
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

An echocardiogram, also called a cardiac ultrasound or echo, is a medical test that takes pictures of the heart using sound waves. It shows images of the structures of the heart without using radiation. During the last year, the FDA has approved a new technology called Speckle Tracking that can look at the heart wall motion and contraction (pumping or squeezing) abnormalities. The study will also employ tissue Doppler and 3-Dimensional echo and uses the same echocardiographic machines which are used right now. The machines are upgraded with the new software application. This new technology is currently being used in adults, but unfortunately, there is almost no published data about normal heart function in infants and children using this technology. It is known from other technologies that the developing child's heart is not the same as an adult.

The investigators wish to study this new technology and compare it to other technologies currently being used.


Condition
Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Speckle Tracking and Function Assessment in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The investigators wish to study a new technology called Speckle Tracking and compare it to other technologies currently being used. [ Time Frame: Retrospective Chart Review ] [ Designated as safety issue: No ]

    An echocardiogram, also called a cardiac ultrasound or echo, is a medical test that takes pictures of the heart using sound waves. It shows images of the structures of the heart without using radiation. During the last year, the FDA has approved a new technology called Speckle Tracking that can look at the heart wall motion and contraction (pumping or squeezing) abnormalities. The study will also employ tissue Doppler and 3-Dimensional echo and uses the same echocardiographic machines which are used right now. The machines are upgraded with the new software application. This new technology is currently being used in adults, but unfortunately, there is almost no published data about normal heart function in infants and children using this technology. It is known from other technologies that the developing child's heart is not the same as an adult.

    The investigators wish to study this new technology and compare it to other technologies currently being used.



Enrollment: 70
Study Start Date: March 2007
Study Completion Date: December 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normals
Cardiomyopathy

Detailed Description:

This study will be done primarily by software analysis.

The investigators wish to enroll a total of 70 patients aged newborn to 17 years old. The patients will be divided into three groups: (1) 0-2 years (2) 2-10 years (3) 10-17 years of age. 59 of the patients will be normal volunteers - siblings of patients receiving routine echoes or siblings of patient caregivers at Children's Healthcare of Atlanta. The investigators will age-match those patients with twenty patients with known or suspected heart muscle dysfunction (not working properly) already scheduled for a routine echo. For the patients scheduled for a routine echo, the patient and parent/guardian will be approached prior to the routine echo being performed. If they consent/assent, it will take an additional 10-15 minutes to obtain the research images after their routine images have been obtained. The healthy volunteers will be screened from the siblings of the patients receiving a routine echo or from siblings of patient caregivers, the study explained and informed consent/assent obtained. It will take approximately 30 minutes to obtain the research images.

By studying this new technology, the investigators will be able to find out whether it will be able to give us useful information on how the heart muscle contracts, the coordination of these contractions and if it may indicate new areas for treatment.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Newborn - 17 year old patients at Children's Healthcare of Atlanta Egleston campus with known or suspected heart muscle dysfunction already scheduled for a routine echo. Also looking at normal controls.

Criteria

Inclusion Criteria:

Healthy Volunteers

  • No known heart disease
  • Age of birth to 17 years.
  • Patients will be compared to age appropriate controls.
  • Stable clinical condition
  • Able and willing to sign informed assent (where appropriate) and consent

Study Group

  • Suspected or known heart muscle dysfunction or cardiomyopathy.
  • Age of birth to 17 years
  • Stable clinical condition
  • Able and willing to sign informed assent (where appropriate) and consent

Exclusion Criteria:

  • Patients who do not have structurally normal left ventricles, have unstable or irregular heart rhythms.
  • Patients not in stable clinical condition
  • Unable or unwilling to sign informed consent and/or assent.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489957

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Derek A Fyfe, MD Emory University
  More Information

No publications provided

Responsible Party: William T. Mahle, MD, Full Professor, Emory University
ClinicalTrials.gov Identifier: NCT00489957     History of Changes
Other Study ID Numbers: IRB00001930
Study First Received: June 20, 2007
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
congenital cardiac disorders
echocardiography

Additional relevant MeSH terms:
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014