NCT01334801

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 378 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Aortic Stenosis
• Disorder of Prosthetic Cardiac Valve
• Aortic Valve Insufficiency
• Mitral Valve Insufficiency
• Hypertrophic Cardiomyopathy
• Tricuspid Valve Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Blood Draw	Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests: 1. BNP (Brain Natriuretic Peptide) 2. (PFA) Platelet Function Analyzer 100 3. von Willebrand Factor (vWF) antigen 4. (vWF) multimers 5. (vWF) \*activity by latex aggregation 6. Plasma stored for development of new testing approaches

Timeline

• Start date: 2010-07-01
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2011-04-13
• Last updated: 2022-05-05

Locations

1 site across 1 country: United States