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CompletedNCT00165945Updated Apr 2, 2012

4-D Visualization Using Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population

An observational study in Congenital Heart Disease, sponsored by Emory University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-04-02.

Sponsored by Emory University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study summary

In this study, the investigators wish to use images obtained from standard of care cardiac MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different computer in order to analyze them with a new computer. The investigators are hoping to better their understanding and management of complex congenital heart disease.

Read the detailed description

All patients enrolled in this study will be receiving standard of care cardiac MRI as prescribed by their physician. These MRI DICOM images will be transferred to a SGI Fuel workstation, where they will be manipulated using the newly developed 4-D Visualization software. No additional scanner time or new imaging sequences are required as presently prescribed sequences and produced data can be analyzed. The workstation is designed to include acceleration hardware for volume rendering, and was developed for advanced cardiac MRI viewing.

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Conditions studied

  • Congenital Heart Disease

Keywords

  • pediatric, cardiology, diagnostic imaging using MRI
03

In context

Heart Defects, Congenital

1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.

This study's enrollment of 500 is above the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.

Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatrics patients in all age groups evaluated with MRI for complex congenital cardiovascular lesions and associated hemodynamics. These are patients coming in for standard of care cardiac MRI's

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scheduled for a cardiac MRI at Children's Healthcare of Atlanta
  • Informed consent
  • meet MRI eligibility inclusion criteria

Exclusion criteria

Exclusion Criteria:

  • Not having a cardiac MRI
  • No informed consent
  • not meeting MRI eligibility exclusion criteria
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (actual)
06

What researchers measure

Primary outcomes

  1. To determine if the 4-D visualization software is beneficial in the investigators' understanding and management of complex congenital heart lesions and their associated hemodynamics/anatomy

    Time frame: throughout study

Secondary outcomes

  1. To study the impact and role of 4-D Visualization on surgical planning and outcome

    Time frame: entire study

07

Study locations

1 site
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30322, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2004, a primary completion of Mar 2009 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 14, 2005
Start
Jun 2004
Primary completionActual
Mar 2009
CompletionActual
Mar 2010
Last update
Apr 2, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00165945
Lead sponsor
Emory University
Collaborators
Children's Healthcare of Atlanta
Responsible party
W. James Parks, MD (Assistant Professor, Emory University) — Principal investigator
First posted
Sep 14, 2005
Start date
Jun 2004
Primary completion
Mar 2009
Completion
Mar 2010
Last update
Apr 2, 2012

Study contacts

W.James Parks, MD
principal investigator · Emory University and Children's Healthcare of Atlanta

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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