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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

June 20, 2007
November 25, 2013
March 2007
May 2008   (final data collection date for primary outcome measure)
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.

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Complete list of historical versions of study NCT00489957 on ClinicalTrials.gov Archive Site
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Speckle Tracking in Pediatric Patients
Speckle Tracking and Function Assessment in Pediatric Patients

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

Cardiomyopathy
Not Provided
  • Normals
  • Cardiomyopathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2009
May 2008   (final data collection date for primary outcome measure)

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.
Both
up to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00489957
IRB00001930
No
William T. Mahle, MD, Emory University
Emory University
Not Provided
Principal Investigator: Derek A Fyfe, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP