MRI Review of Tracheal Dimensions

Status Terminated

Clinical Trial Summary

Clinical Trial 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 stenosis/deformity 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 (i.e. respiratory symptoms, abnormal echocardiogram, abnormal CXR or barium swallow). ;

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Congenital Disorders

Clinical Trial Details

NCT number	NCT00277953
Study type	Observational
Source	Children's Healthcare of Atlanta
Contact
Status	Terminated
Phase	N/A

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.