Speckle Tracking in Pediatric Patients

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00489957
Study type	Observational
Source	Emory University
Contact
Status	Completed
Phase	N/A
Start date	March 2007
Completion date	December 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.