BASS
Biomarkers in Aortic Stenosis, Hypertrophic Cardiomyopathy, Mitral Regurgitation, Aortic Regurgitation, Prosthetic Heart Valve Dysfunction, and Tricuspid Regurgitation From Pacemaker Leads Study
Sponsor study identifier
observational
378
1 country
1
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 31, 2020
Actual (reported)Study Completion
January 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 12, 2011
Actual (reported)April 13, 2011
Actual (reported)January 31, 2020
Actual (reported)January 31, 2020
Actual (reported)Correlation of Von Willebrand Multimer ratio to cardiac lesion severity
To accomplish the specific aims, the investigators propose to collect clinical and echocardiographic data, and blood samples for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and BNP in patients with aortic stenosis, or aortic or mitral valve prosthesis, mitral regurgitation, hypertrophic cardiomyopathy, aortic regurgitation, and tricuspid regurgitation associated with pacemaker or defibrillator.
2 years
Correlation of other VWF activity measures with cardiac lesion severity.
2 years
Restricted aortic valve motion and a peak Doppler aortic velocity \> 2.5 m/sec blood draw
Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume
Mechanical or biological aortic valve replacement
Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume
Mechanical or biological mitral valve replacement
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
Cardiology, referred for clinically-indicated echocardiograms
Mayo Clinic
Jacksonville, Florida, 32224, United States
Blackshear JL, Stark ME, Agnew RC, Moussa ID, Safford RE, Shapiro BP, Waldo OA, Chen D. Remission of recurrent gastrointestinal bleeding after septal reduction therapy in patients with hypertrophic obstructive cardiomyopathy-associated acquired von Willebrand syndrome. J Thromb Haemost. 2015 Feb;13(2):191-6. doi: 10.1111/jth.12780. Epub 2014 Dec 12.
whole blood
Joseph L Blackshear, M.D.
Mayo Clinic
378 participants (actual enrollment reported by the registry).
First Submitted
April 12, 2011
First Posted
April 13, 2011
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Spectroscopy in Parkinson Disease
Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography
Patients referred for clinically indicated echocardiography who have severe tricuspid regurgitation associated with a pacemaker or defibrillator lead documented by echocardiography
Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence.
Patients with no heart murmur or history of valve replacement, stenosis, regurgitation, or hypertrophic cardiomyopathy
Patients with previously implanted LVAD
Patients on hemodialysis, peritoneal dialysis, or chronic kidney disease with dialysis fistula to be created.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 31, 2020
Actual (reported)Study Completion
January 31, 2020
Actual (reported)Last Updated
May 5, 2022
Record last verified: 2022-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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