Bicuspid Aortic Valve Registry (BAV)

This study is currently recruiting participants.
Verified January 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Anna Booher, University of Michigan
ClinicalTrials.gov Identifier:
NCT01756222
First received: December 19, 2012
Last updated: January 3, 2013
Last verified: January 2013

December 19, 2012
January 3, 2013
April 2010
December 2040   (final data collection date for primary outcome measure)
Characterizing patients with bicuspid aortic valve disease [ Time Frame: 30 years ] [ Designated as safety issue: No ]
Identifying patients with bicuspid aortic valve disease, assessing the effect of medical intervention.
Same as current
Complete list of historical versions of study NCT01756222 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bicuspid Aortic Valve Registry
Bicuspid Aortic Valve and Ascending Aortic Aneurysm Registry

The purpose of this registry is to gather information on patients with bicuspid aortic valve disease. The data collected in the registry will be used to assess patterns of aortic dilation, responses to medical therapy based on serial imaging and to assess for potential genetic markers of this disease

Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
30 Years
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

Primary clinic

Bicuspid Aortic Valve Disease
Not Provided
Bicuspid Aortic Valve Disease Patients
Patients with the diagnosis of BAV disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2040
December 2040   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient over the age of 18 who is able/willing to give informed consent with the diagnosis of bicuspid aortic valve disease, a family history of this disease or an ascending aortic aneurysm that is idiopathic can be included in the registry.

Exclusion Criteria:

  • Patients unable or unwilling to give informed consent.
Both
18 Years and older
Yes
Contact: Nickole Calson, BSN 734-232-4780 ngarvey@med.umich.edu
United States
 
NCT01756222
HUM00035836
Yes
Anna Booher, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Anna Booher, MD University of Michigan
University of Michigan
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP