Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI

NCT00489788 | Completed

• 1 other identifier: IRB00000990
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

Magnetic Resonance Imaging (MRI) is a non-invasive test that can look at the heart without using radiation. An MRI will allow the doctors to look at the heart in order to assess how well the ventricle is pumping, the amount of blood that it is pumping in addition to how much it is stretching. An engineer at Georgia Tech has developed a new way of looking at an MRI. It is believed that this new way of looking at an MRI may be better able to tell us when to replace the valve in these children. If this new process works, not only can we apply it now but we will be able to look at previously performed MRIs and gather more information about these children and their heart function in order to help these and other children in the future. We are planning on enrolling 30 subjects in this study. Some of the subjects will be enrolled and have their MRI strictly for the purpose of this study. Some of the subjects will be already scheduled for a routine MRI of their heart and we will ask them if we can do extra images for the study while they are already here.

Conditions

Congenital Disorders

Keywords

MRI; Ventricular Strain; Pulmonary Valve Replacement; Post Tetralogy of Fallot

Eligibility Criteria

• Age: 3 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatrics and young adults aged 3-30 years following surgical repair of Tetralogy of Fallot. Also looking at normal control subjects.

You may qualify if:

• Thirty (30) patients diagnosed with Tetralogy of Fallot.
• Ten (10) patients with previously repaired post-PVR.
• Ten (10) normal control subjects.
• Meet the eligibility criteria for MRI.
• Age range: 3-30 years
• Informed consent being obtained from the legal guardians and/or patients.

You may not qualify if:

• Outside target age range.
• Contra-indications to MRI such as metallic implants
• Acquired (non-congenital) heart disease

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• W.James Parks, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 21, 2007
• Study Start: September 1, 2008
• Study Completion: March 1, 2009
• Last Updated: December 11, 2013

Record last verified: 2013-12