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NCT00412386 · ClinicalTrials.gov registry record
Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 45
- Enrollment target
NCT00412386: Completed study, sponsored by Emory University.
NCT00412386 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412386 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
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 t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-03 |
What the finished NCT00412386 record still lists
NCT00412386 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00412386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00412386 about?
NCT00412386 is a clinical study titled "Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve". 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 leafl...
What is the current status of trial NCT00412386?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2006-12. Estimated completion is 2012-03.
Who is sponsoring clinical trial NCT00412386?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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