Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489957
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2007-06-20
Brief Title:
Speckle Tracking in Pediatric Patients
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Speckle Tracking and Function Assessment in Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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
The investigators wish to study this new technology and compare it to other technologies currently being used
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 Childrens 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 parentguardian will be approached prior to the routine echo being performed If they consentassent 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 consentassent 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
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 Childrens 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 parentguardian will be approached prior to the routine echo being performed If they consentassent 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 consentassent 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None