Biomarkers in Aortic Stenosis - B.A.S.S.



Status:Recruiting
Conditions:High Cholesterol, Cardiology, Cardiology, Cardiology, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:21 - Any
Updated:4/17/2018
Start Date:July 2010
End Date:December 31, 2025
Contact:Marcia F Dubin
Email:dubin.marcia@mayo.edu
Phone:904-953-8268

Use our guide to learn which trials are right for you!

Biomarkers in Aortic Stenosis, Hypertrophic Cardiomyopathy, Mitral Regurgitation, Aortic Regurgitation, Prosthetic Heart Valve Dysfunction, and Tricuspid Regurgitation From Pacemaker Leads Study

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
We found this trial at
1
site
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials