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

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ClinicalTrials.gov Identifier: NCT00165945
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 2, 2012
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
W. James Parks, MD, Emory University

Brief 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.

Condition or disease
Congenital Heart Disease

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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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using 4-D Visualization Software With Magnetic Resonance Images in the Congenital Heart Disease Population
Study Start Date : June 2004
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  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 Outcome Measures :
  1. To study the impact and role of 4-D Visualization on surgical planning and outcome [ Time Frame: entire study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165945


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: W.James Parks, MD Emory University and Children's Healthcare of Atlanta

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Responsible Party: W. James Parks, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00165945     History of Changes
Other Study ID Numbers: 075-2004
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by W. James Parks, MD, Emory University:
pediatric, cardiology, diagnostic imaging using MRI

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities