Biomarkers in Aortic Stenosis - B.A.S.S.
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the
 severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral
 regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and
 tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under
 study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von
 Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the
 blood tests will be compared to the information from the clinically-indicated echocardiogram
 and one blood test compared to another.
Patients with aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic
 regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve
 regurgitation associated with pacemaker leads who are referred for clinically-indicated
 echocardiographic exams at Mayo Clinic, in Jacksonville, Florida will be screened for
 participation in the study. The plan is to have 292 people take part in this study. This
 minimal risk study will consist of the recording of patient data, activity and bleeding
 questionnaires, and collection and analysis of blood samples. Each blood sample will be
 analyzed for von Willebrand Factor antigen and activity, and von Willebrand Factor multimers,
 and BNP. Blood samples will be sent to the Mayo Special Coagulation Lab for analysis.

 Objective:

 This study seeks to assess the degree of association of the von Willebrand Factor activity
 indices and BNP to the severity of cardiac lesions, and to note a relationship between
 acquired bleeding the the hematologic abnormalities. Plasma will be stored in attempt to
 develop new in vitro tests of von Willebrand factor (VWF) activity.
Inclusion Criteria:

 -  patients with mild, moderate, or severe aortic stenosis or aortic or mitral
 prosthesis. Patients with aortic or mitral regurgitation. patients with hypertrophic
 cardiomyopathy. Patients with dysfunctional heart valve replacement or repair.
 Patients with severe tricuspid regurgitation associated with pacemaker or
 defibrillator lead. Ten normal control patients who will not be required to have
 echocardiography

 -  referred for a clinically indicated echocardiogram; the echo must be of good quality
 and specifically have patient height, weight, left ventricular outflow tract diameter,
 subaortic velocity profile by Doppler, and aortic transvalvular continuous wave
 Doppler velocity profile. For mitral regurgitation and aortic regurgitation the data
 must be adequate to allow calculation of regurgitant volume. For hypertrophic
 cardiomyopathy, a recording of left ventricular outflow tract peak velocity must be
 recorded

 -  21 years or older

 -  patients with aortic stenosis, defined as peak aortic velocity greater than 2.5 m/sec
 with evidence of aortic valve thickening, or an aortic or mitral valve prosthesis

 -  able to provide written informed consent

 Exclusion Criteria:

 -  Missing or inadequate echocardiographic data

 -  inability to give informed consent

 -  inability to provide a research blood sample

 -  hemoglobin less than 8

 -  severe valvular regurgitation

 -  stenosis of the mitral valve