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

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Denver Sallee, Emory University
ClinicalTrials.gov Identifier:
NCT00412386
First received: December 14, 2006
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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
Congenital Heart Disease
Bicuspid Aortic Valve

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Enrollment: 45
Study Start Date: December 2006
Study Completion Date: March 2012
Groups/Cohorts
BAV
patients with BAV
Normal control
normal patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412386

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

Publications:
Responsible Party: Denver Sallee, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00412386     History of Changes
Other Study ID Numbers: IRB00000134
Study First Received: December 14, 2006
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Pediatric
Congenital Heart Disease
Imaging

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014