Aortic Arch Reconstruction
|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.|
|ClinicalTrials.gov Identifier: NCT00277940|
Recruitment Status : Terminated
First Posted : January 18, 2006
Last Update Posted : July 6, 2011
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Neoaortic Elastic Properties After Aortic Arch Reconstruction|
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 ClinicalTrials.gov identifier (NCT number): NCT00277940
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||William T Mahle, MD||Children's Healthcare of Atlanta|