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MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277901
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : December 2, 2014
Information provided by:
Children's Healthcare of Atlanta

Brief Summary:
At Children's Healthcare of Atlanta at Egleston, it is standard of care to do a cardiac MRI on patients with the diagnosis of Tetralogy of Fallot and Aortic Coarctation to evaluate heart function. We propose to do a retrospective chart review of patient data along with their MRI data to analyze ventricular function and cavity volumes pre-Tetralogy of Fallot repair, post-Tetralogy of Fallot repair (pre-valve repair/replacement) and post-valve repair/replacement in order to assess the efficacy and optimal timing of valve replacement.

Condition or disease
Congenital Disorders

Detailed Description:

Patients with Tetralogy of Fallot have various degrees and levels of right ventricular outflow tract obstruction. They undergo surgical removal of the obstructing structures, which includes the pulmonary valve. The repair of the outflow tract is done utilizing a transannular patch. This approach, which is considered the standard of care, results in free pulmonary insufficiency, which may become severe and lead to right heart overloading and subsequent dilatation and dysfunction. This chronic overloading results in progressive tricuspid insufficiency and a suspected decline in effective pulmonary blood flow, cardiac output and right ventricle functional capabilities. Many patients develop progressive exercise intolerance, arrhythmias and severe cardiomegaly leading to dilated cardiomyopathy. The progressive decline in patient clinical status results in recommendations of pulmonary valve replacement to interrupt further dysfunction of the ventricles. Clinical improvement is generally seen among the patients and cardiac function is measurably improved in many cases, however the timing of surgery remains undefined and its impact on function improvement and recovery post -valve replacement is under serious debate and continuous discussion.

Preliminary work suggests that Magnetic Resonance Imaging (MRI) determined right to left ventricular volume ratio's of greater than 2:1 with associated tricuspid regurgitation, right ventricular regurgitant volumes of greater than 50%, and right ventricular ejection fractions less than 45% are common among patients with severe right ventricular failure and dysfunction. These patients are in need of pulmonary valve replacement and have routinely been referred for surgical intervention.

Patients with Aortic Coarctation have a localized malformation characterized by deformity of the aortic media, causing narrowing, usually severe, of the lumen of the vessel. Surgical repair or removal of this malformation is the treatment of choice however; the use of MRI to better determine the extent of damage or malformation would allow the surgeon to plan an operative strategy prior to opening the chest.

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Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: MRI Assessment of Two Congenital Heart Disease States: Assessment of Right Ventricular Function: Predictor of Optimal Timing of Pulmonary Valve Replacement in Patients With TOF; Assessment of Flow Dynamics in Patients With Aortic Coarctation
Study Start Date : March 2002
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. (1) Determine Right and left ventricular volumes during all phases of the cardiac cycle. [ Time Frame: 7 years ]
    (1) Determine Right and left ventricular volumes during all phases of the cardiac cycle.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston

Inclusion Criteria:

  • Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston.

Exclusion Criteria:

  • Those patients who do not meet the inclusion 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 identifier (NCT number): NCT00277901

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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
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Principal Investigator: James Parks, MD Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
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Responsible Party: James Parks, MD, Children's Healthcare of Atlanta Institutional Review Board Identifier: NCT00277901    
Other Study ID Numbers: 02-122
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Children's Healthcare of Atlanta:
Tetralogy of Fallot TOF
Aortic Coarctation
Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities