Congenital DisordersNCT00277940
Aortic Arch Reconstruction
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Abnormalities of the aorta have been identified in patients who have undergone repair of coarctation of the aorta by various surgical techniques. These abnormalities are thought to contribute to ventricular hypertrophy, hypertension and exercise intolerance. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: retro chart review
Who may be able to join
- Single ventricle congenital heart disease 1) palliated with bi-directional Glenn procedure after having the Norwood procedure (experimental group) or 2) palliated with the bi-directional Glenn without having the Norwood procedure as stage I palliation-i.e. Tricuspid Atresia, Pulmonary Atresia (control group)
- Undergoing routine Fontan procedure
Who cannot join
- Semi-lunar valve insufficiency > trivial
- Residual coarctation noted on routine pre-Fontan catheterization
- Those who do not meet 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: Neoaortic Elastic Properties After Aortic Arch Reconstruction
Abnormalities of the aorta have been identified in patients who have undergone repair of coarctation of the aorta by various surgical techniques. These abnormalities are thought to contribute to ventricular hypertrophy, hypertension and exercise intolerance. Aortic arch reconstruction is performed for a variety of lesions besides simple coarctation of the aorta; these include hypoplastic left heart syndrome and its variants. In the latter group of patients extensive reconstruction is performed usually with a pulmonary homograft. We have previously shown that the neo-aortic dimensions and geometry are abnormal. The elastic properties of the neo-aorta, however, have not previously been described.
Read the detailed description
In the present study we proposed to examine neo-aortic properties in a cohort of children with single ventricle heart defects who have undergone the bi-directional Glenn procedure (with or without Norwood palliation) and compare them to a cohort of patients with single ventricle who have had no aortic arch interventions. Patients in both groups typically undergo the Fontan operation between 18-48 months of age. After arrival to the operating suite and the placement of routine instrumentation, a transesophageal echocardiography (TEE) is routinely obtained. All data needed for this protocol is obtained during this TEE.
The stiffness of the aorta will be determined by calculating the pressure-strain elastic modulus (Ep) and the stiffness index beta (β). They are calculated from the formula Ep=[Ps-Pd]/[Ds-Dd/Dd] and β = [ln Ps/Pd[Ds-Dd]. Pressure-strain elastic modulus measurements have been utilized to measure the stiffness of the aorta and carotid arteries in both adults and children with a high reproducibility and low interobserver variability. The stiffness index beta has been proposed as a better measure of aortic stiffness because of its independence from measured blood pressure. The ability of a vessel to distend to store extra volume due to pressure effects is known as its compliance. A vessel with a higher compliance will be more "stretchy" and will therefore be more favorable to holding a greater volume of blood rather than storing a lot of pressure energy. Conversely, a vessel with a lower compliance will be less "stretchy" and therefore be more favorable to storing a lot of pressure energy rather than holding a greater volume of blood. Essentially, if two vessels are of equal size (cross-sectional flow area and volume), but one vessel has a lower compliance, then a 1 milliliter change in volume of the lower compliance (less stretchy) vessel will result in a greater pressure increase than a 1 milliliter change in volume of the higher compliance (more stretchy) vessel. Compliance will be assessed by the use of automatic border detection. This provides a continuous measure of the vessel cross-sectional area over time. Compliance is calculated by (Areamax-Areamean/mean blood pressure).
Blood pressure data will be recorded simultaneously with an arterial catheter that is used routinely during the operation.
- Conditions
- Congenital Disorders
- Keywords
- Pediatric, Cardiac, Neoaortic Elastic Properties, Aortic Arch Reconstruction
- 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 posted18 Jan 2006 (estimated)
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
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- William T Mahle, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277940
- Sponsor's protocol ID
- 03-042
- Status last verified
- May 2007
- First submitted
- 13 Jan 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoaortic Elastic Properties After Aortic Arch Reconstruction
- ClinicalTrials.gov ID
- NCT00277940
- Acronym / sponsor ID
- 03-042
- Conditions
- Congenital Disorders
- Keywords
- Pediatric, Cardiac, Neoaortic Elastic Properties, Aortic Arch Reconstruction
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- 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.
Abnormalities of the aorta have been identified in patients who have undergone repair of coarctation of the aorta by various surgical techniques. These abnormalities are thought to contribute to ventricular hypertrophy, hypertension and exercise intolerance. Aortic arch reconstruction is performed for a variety of lesions besides simple coarctation of the aorta; these include hypoplastic left heart syndrome and its variants. In the latter group of patients extensive reconstruction is performed usually with a pulmonary homograft. We have previously shown that the neo-aortic dimensions and geometry are abnormal. The elastic properties of the neo-aorta, however, have not previously been described.
Detailed description
In the present study we proposed to examine neo-aortic properties in a cohort of children with single ventricle heart defects who have undergone the bi-directional Glenn procedure (with or without Norwood palliation) and compare them to a cohort of patients with single ventricle who have had no aortic arch interventions. Patients in both groups typically undergo the Fontan operation between 18-48 months of age. After arrival to the operating suite and the placement of routine instrumentation, a transesophageal echocardiography (TEE) is routinely obtained. All data needed for this protocol is obtained during this TEE.
The stiffness of the aorta will be determined by calculating the pressure-strain elastic modulus (Ep) and the stiffness index beta (β). They are calculated from the formula Ep=[Ps-Pd]/[Ds-Dd/Dd] and β = [ln Ps/Pd[Ds-Dd]. Pressure-strain elastic modulus measurements have been utilized to measure the stiffness of the aorta and carotid arteries in both adults and children with a high reproducibility and low interobserver variability. The stiffness index beta has been proposed as a better measure of aortic stiffness because of its independence from measured blood pressure. The ability of a vessel to distend to store extra volume due to pressure effects is known as its compliance. A vessel with a higher compliance will be more "stretchy" and will therefore be more favorable to holding a greater volume of blood rather than storing a lot of pressure energy. Conversely, a vessel with a lower compliance will be less "stretchy" and therefore be more favorable to storing a lot of pressure energy rather than holding a greater volume of blood. Essentially, if two vessels are of equal size (cross-sectional flow area and volume), but one vessel has a lower compliance, then a 1 milliliter change in volume of the lower compliance (less stretchy) vessel will result in a greater pressure increase than a 1 milliliter change in volume of the higher compliance (more stretchy) vessel. Compliance will be assessed by the use of automatic border detection. This provides a continuous measure of the vessel cross-sectional area over time. Compliance is calculated by (Areamax-Areamean/mean blood pressure).
Blood pressure data will be recorded simultaneously with an arterial catheter that is used routinely during the operation.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- retro chart review
Key inclusion criteria (2 listed)
- Single ventricle congenital heart disease 1) palliated with bi-directional Glenn procedure after having the Norwood procedure (experimental group) or 2) palliated with the bi-directional Glenn without having the Norwood procedure as stage I palliation-i.e. Tricuspid Atresia, Pulmonary Atresia (control group)
- Undergoing routine Fontan procedure
Key exclusion criteria (3 listed)
- Semi-lunar valve insufficiency > trivial
- Residual coarctation noted on routine pre-Fontan catheterization
- Those who do not meet 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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
William T Mahle, MD principal investigator
Children's Healthcare of Atlanta
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 2 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: stopped early, as of the sponsor's last update on 6 Jul 2011. 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 was stopped early. Results are not available in the source record.
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 6 Jul 2011.