Speckle Tracking in Pediatric Patients

NCT00489957 | Completed

• 1 other identifier: IRB00001930
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiomyopathy

Keywords

congenital cardiac disorders; echocardiography

Outcome Measures

Primary Outcomes (1)

• 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.

  Retrospective Chart Review

Study Arms (2)

Normals

Cardiomyopathy

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Derek A Fyfe, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2009
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)