Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489788
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2007-06-19
Brief Title:
Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
MRI Assessment of Right and Left Ventricular Strain Associated Function Volume and ECG Parameters as Predictors of Optimal Timing for Pulmonary Valve Replacement in Patients Post Repair for Tetralogy of Fallot
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Cardiovascular disease remains a leading cause of morbidity and death in the Western World Assessment of Myocardial function has proven to be a clinically relevant method for monitoring and evaluating outcomes of medical therapy and surgery for structural lesions or acquired disease
Tetralogy of Fallot TOF is the most common form of cyanotic congenital heart disease with a prevalence of 026 to 08 per 1000 live births The current surgical approach favors primary repair in infancy This decreases the necessity for palliative procedures and has a low operative mortality Complete repair often results in pulmonary regurgitation PR which is generally well tolerated in infancy Late complications may include ventricular dilatation tricuspid regurgitation diastolic and systolic dysfunction arrhythmias and sudden cardiac death
Pulmonary valve replacement PVR is required in approximately 20 of patients with repaired TOF and has a 1-4 peri-operative mortality Thus early intervention may reduce irreversible right ventricle injury however no definitive tools are presently available for determining patients at risk
Myocardial strain analysis has not been critically evaluated to determine its value for predicting RV failure This study will investigate the practicality and accuracy of a novel mathematical method developed by the investigators for analysis of cardiac deformation recovery from dynamic Cardiovascular Magnetic Resonance Imaging CMRI sequences The proposed method requires structural MRI data offering several important advantages over existing methods These include reduced requirements in imaging time and analysis effort and the option to use a large database of prior structural MRI studies of TOF patients in retrospective research
This three-dimensional method is mathematically based on nearly incompressible tissue deformations The project proposes validation of technique comparing its results with current gold standard methods that presently use CMRI myocardial tagging and phase velocity mapping as a pilot study for clinical validation of strain imaging in TOF patients The method tracks movement of myocardial tissue throughout the cardiac cycle to compute strain associated with normal and a clinical disease state
During the study we will customize the method and software for specific use with CMRI and TOF We will test the method on normal controls and TOF patients pre and post pulmonary valve replacement
Tetralogy of Fallot TOF is the most common form of cyanotic congenital heart disease with a prevalence of 026 to 08 per 1000 live births The current surgical approach favors primary repair in infancy This decreases the necessity for palliative procedures and has a low operative mortality Complete repair often results in pulmonary regurgitation PR which is generally well tolerated in infancy Late complications may include ventricular dilatation tricuspid regurgitation diastolic and systolic dysfunction arrhythmias and sudden cardiac death
Pulmonary valve replacement PVR is required in approximately 20 of patients with repaired TOF and has a 1-4 peri-operative mortality Thus early intervention may reduce irreversible right ventricle injury however no definitive tools are presently available for determining patients at risk
Myocardial strain analysis has not been critically evaluated to determine its value for predicting RV failure This study will investigate the practicality and accuracy of a novel mathematical method developed by the investigators for analysis of cardiac deformation recovery from dynamic Cardiovascular Magnetic Resonance Imaging CMRI sequences The proposed method requires structural MRI data offering several important advantages over existing methods These include reduced requirements in imaging time and analysis effort and the option to use a large database of prior structural MRI studies of TOF patients in retrospective research
This three-dimensional method is mathematically based on nearly incompressible tissue deformations The project proposes validation of technique comparing its results with current gold standard methods that presently use CMRI myocardial tagging and phase velocity mapping as a pilot study for clinical validation of strain imaging in TOF patients The method tracks movement of myocardial tissue throughout the cardiac cycle to compute strain associated with normal and a clinical disease state
During the study we will customize the method and software for specific use with CMRI and TOF We will test the method on normal controls and TOF patients pre and post pulmonary valve replacement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None