Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve

Completed

Conditions studied: Congenital Heart Disease, Bicuspid Aortic Valve

In brief

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.

Key facts

Study ID

NCT00412386

Run by

Emory University

People needed

45

Starts

2006-12-01

Expected to finish

2012-03-01

Last updated by the study team

2013-12-03

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• diagnosed with Bicuspid Aortic Valve 15 with aortic root dilatation 15 without aortic root dilatation
• 15 patients with congenital heart disease, but not bicuspid aortic valve
• meet eligibility criteria for MRI
• 10-18 years of age

You may not qualify if…

• under 10 years and over 19 years of age
• systemic hypertension for age and height
• Marfan syndrome
• on cardiac or vasoactive medications
• contra-indications to MRI such as metallic implants
• acquired heart disease
• require sedation

Where it is running

• Childrens Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.