Congenital DisordersNCT00277901
MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jul 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston.
Who cannot join
- Those patients who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
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
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.
Read the 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.
- Conditions
- Congenital Disorders
- Keywords
- cardiac, pediatric, MRI, Tetralogy of Fallot TOF, Aortic Coarctation
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Aortic Coarctation
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) Determine Right and left ventricular volumes during all phases of the cardiac cycle.
(1) Determine Right and left ventricular volumes during all phases of the cardiac cycle.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startMar 2002
- Primary completionJul 2009
- Study completionJul 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.
- 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
- Retrospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- James Parks, MD, Principal investigator, Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277901
- Sponsor's protocol ID
- 02-122
- Status last verified
- Nov 2014
- First submitted
- 13 Jan 2006
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00277901
- Acronym / sponsor ID
- 02-122
- Conditions
- Congenital Disorders
- Keywords
- cardiac, pediatric, MRI, Tetralogy of Fallot TOF, Aortic Coarctation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Jan 2006 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Patients with the diagnosis of Tetralogy of Fallot or Aortic Coarctation being Treated at Children's Healthcare of Atlanta at Egleston.
Key exclusion criteria (1 listed)
- Those patients who do not meet the inclusion criteria
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
(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.
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 2 Dec 2014.
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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.
James Parks, MD principal investigator
Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
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 1 inclusion and 1 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
(1) Determine Right and left ventricular volumes during all phases of the cardiac cycle. (time frame: 7 years). It is what the study was designed to measure, not a finding.
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 2 Dec 2014.