Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00277953
Status:
TERMINATED
Last Update Posted:
2007-05-04
First Post:
2006-01-13
Brief Title:
MRI Review of Tracheal Dimensions
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
A Review of Tracheal Dimensions in the Pediatric Population Using MRI
Status:
TERMINATED
Status Verified Date:
2007-05
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:
To date there have been no published reports of normal variations in tracheal dimensions for pediatric patients undergoing MRIs While there are reports of normals in CT studies the reported dimensions were for average areas and lengths over the entire length of the trachea and not for normal variation in the dimensions at various sites in the trachea Moreover CT measurements are likely not entirely applicable to MRI measurements Since cardiac MRI has become the procedure of choice to document the presence of vascular rings as well as the significance of any ring that is found there is a need for normal values to be generated This would in turn permit physicians to determine in cases of documented vascular rings the severity of the tracheal stenosisdeformity if found
Detailed Description:
To date there have been no published reports of normal variations in tracheal dimensions for pediatric patients undergoing MRIs While there are reports of normals in CT studies the reported dimensions were for average areas and lengths over the entire length of the trachea and not for normal variation in the dimensions at various sites in the trachea Moreover CT measurements are likely not entirely applicable to MRI measurements Since cardiac MRI has become the procedure of choice to document the presence of vascular rings as well as the significance of any ring that is found there is a need for normal values to be generated This would in turn permit physicians to determine in cases of documented vascular rings the severity of the tracheal stenosisdeformity if found
Hypothesis Patients referred for cardiac MRIs to evaluate vascular rings will have significantly smaller tracheal dimensions area longest width shortest width based on a percentage of their maximal tracheal dimension in comparison with patients referred for cardiac MRIs for other indications
I would propose to retrospectively review cardiac MRIs for tracheal dimensions in 25 consecutive patients referred for possible vascular rings and for 50 consecutive patients undergoing cardiac MRIs for other indications As part of this study I would also propose to review the clinical findings that prompted the cardiac MRI to be ordered ie respiratory symptoms abnormal echocardiogram abnormal CXR or barium swallow
Hypothesis Patients referred for cardiac MRIs to evaluate vascular rings will have significantly smaller tracheal dimensions area longest width shortest width based on a percentage of their maximal tracheal dimension in comparison with patients referred for cardiac MRIs for other indications
I would propose to retrospectively review cardiac MRIs for tracheal dimensions in 25 consecutive patients referred for possible vascular rings and for 50 consecutive patients undergoing cardiac MRIs for other indications As part of this study I would also propose to review the clinical findings that prompted the cardiac MRI to be ordered ie respiratory symptoms abnormal echocardiogram abnormal CXR or barium swallow
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