Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve
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|ClinicalTrials.gov Identifier: NCT00412386|
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : December 3, 2013
Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the heart to the body) are not formed right. A person with BAV has only 2 leaflets instead of three and the valve leaflets are often thickened. This can result in the block of blood flow across the valve (aortic stenosis) and/or valve leakage (aortic valve regurgitation).
From our experience at least 1/3 of patients with BAV will eventually develop complications. Many patients with BAV do not develop significant problems until well into adulthood. The most common problem in BAV patients is aortic dilatation and/or dissection. At this point, we do not know on who or why aortic dilatation or dissection occurs.It is unclear whether the enlargement is because of abnormal blood flow patterns, as a result of the shape of the bicuspid valve, or whether it is because the way the aortic valve and/or vessel is formed. In other words, the abnormal shape of the aortic valve may cause blood to flow in a different way than it normally would, causing damage to the aorta as blood leaves the heart. There may be a problem with the way the aortic valve connects to the aorta, which causes the aorta to get larger or break down over time. It is also possible that the wall of the aorta in patients with BAV is weaker than it would be in patients without BAV. At this point, we do not know. It is believed by the investigators that if we can determine why the aorta gets larger or tears, we can minimize the effects or prevent them altogether.
This study will collect blood and cardiac MRI images from forty-five (45) patients at Children's Healthcare of Atlanta Egleston. There will be a study group (patients with BAV) and a control group of patients (patients scheduled for a cardiac MRI but without BAV).
All enrolled patients will have blood drawn by nursing staff from a peripheral vein and collected in tubes for testing the day of their MRI scan. This test is called a plasma matrix metalloproteinase level. It is believed that patients who have bicuspid aortic valves and dilated aortas have high plasma levels of this protein. This study will compare the MRI images and plasma matrix protein levels of all the patients participating in the study.
|Condition or disease|
|Congenital Heart Disease Bicuspid Aortic Valve|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Observational Model:||Case Control|
|Official Title:||Abnormal 3-dimensional MRI Flow Patterns and Plasma Matrix Metalloproteinase Levels Predict Dilatation of Ascending Aorta in Adolescent Patients With Bicuspid Aortic Valve|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||March 2012|
patients with BAV
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): NCT00412386
|United States, Georgia|
|Childrens Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Denver Sallee, MD||Emory University|