NCT00277953

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 stenosis/deformity if found.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
Last Updated

May 4, 2007

Status Verified

May 1, 2007

First QC Date

January 13, 2006

Last Update Submit

May 2, 2007

Conditions

Congenital Disorders

Keywords

PediatricCardiacTracheal DimensionsMRI

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • consecutive patients referred for possible vascular rings 50 consecutive patients undergoing cardiac MRIs for other indications adequate axial double-inversion recovery images of sufficient quality to permit accurate measurement of variations in tracheal dimension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Denver Sallee III, MD

    Children's Healthcare of Atlanta, Sibley Heart Center Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Last Updated

May 4, 2007

Record last verified: 2007-05

Locations

US(1)