Congenital DisordersNCT00489788
Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI
An observational study of Congenital Disorders, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Disorders
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatrics and young adults aged 3-30 years following surgical repair of Tetralogy of Fallot. Also looking at normal control subjects.
Who may be able to join
- 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.
Who cannot join
- Outside target age range.
- Contra-indications to MRI such as metallic implants
- Acquired (non-congenital) heart disease
About this study
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
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.
Read the 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 0.26 to 0.8 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.
- Conditions
- Congenital Disorders
- Keywords
- MRI, Ventricular Strain, Pulmonary Valve Replacement, Post Tetralogy of Fallot
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, W. James Parks, MD, Emory University
- Investigators
- W.James Parks, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489788
- Sponsor's protocol ID
- IRB00000990
- Status last verified
- Dec 2013
- First submitted
- 19 Jun 2007
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00489788
- Acronym / sponsor ID
- IRB00000990
- Conditions
- Congenital Disorders
- Keywords
- MRI, Ventricular Strain, Pulmonary Valve Replacement, Post Tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Sep 2008
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 0.26 to 0.8 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatrics and young adults aged 3-30 years following surgical repair of Tetralogy of Fallot. Also looking at normal control subjects.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Outside target age range.
- Contra-indications to MRI such as metallic implants
- Acquired (non-congenital) heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W.James Parks, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.