An observational study in Cardiomyopathy, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 1 Day to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-27.
Sponsored by Emory University · Observational
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 70 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Healthy Volunteers
Study Group
Exclusion Criteria:
The investigators wish to study a new technology called Speckle Tracking and compare it to other technologies currently being used.
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.
Time frame: Retrospective Chart Review
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Emory University