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

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. Identifier: NCT00412386
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : December 3, 2013
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Denver Sallee, Emory University

Brief 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 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

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

patients with BAV
Normal control
normal patients

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with bicuspid Aortic valve, normal healthy volunteers, and congential heart disease without bicuspid aortic valve

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00412386

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United States, Georgia
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
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Principal Investigator: Denver Sallee, MD Emory University

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Responsible Party: Denver Sallee, Assistant Professor, Emory University Identifier: NCT00412386     History of Changes
Other Study ID Numbers: IRB00000134
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by Denver Sallee, Emory University:
Congenital Heart Disease

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities