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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Stenosis | Restricted aortic valve motion and a peak Doppler aortic velocity > 2.5 m/sec blood draw |
| |
| Aortic regurgitation | Echocardiographic and Doppler evaluation revealing aortic regurgitation with data adequate to calculate regurgitant volume |
| |
| Aortic valve replacement | Mechanical or biological aortic valve replacement |
| |
| Mitral regurgitation | Echocardiographic and Doppler evaluation revealing mitral regurgitation with data adequate to calculate regurgitant volume |
| |
| Mitral valve replacement | Mechanical or biological mitral valve replacement |
| |
| Hypertrophic cardiomyopathy | Patients with known hypertrophic cardiomyopathy who are referred for clinically indicated echocardiography |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Procedure | Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of other VWF activity measures with cardiac lesion severity. | Comprehensively analyze the ability of VWF indices to discriminate severe from non-severe valvular disease, prosthetic valve dysfunction, and describe the prevalence of VWF abnormalities in this wide range of cardiac lesions associated with intravascular turbulence. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiology, referred for clinically-indicated echocardiograms
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| Name | Affiliation | Role |
|---|---|---|
| Joseph L Blackshear, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25387993 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| D008944 | Mitral Valve Insufficiency |
| D002312 | Cardiomyopathy, Hypertrophic |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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whole blood
|
| Severe TR with pacemaker / ICD lead | Patients referred for clinically indicated echocardiography who have severe tricuspid regurgitation associated with a pacemaker or defibrillator lead documented by echocardiography |
|
| Prosthetic valve dysfunction | Patients with prior heart valve replacement or repair referred for clinically indicated echocardiography who demonstrate stenosis, regurgitation, dehiscence. |
|
| Normal controls | Patients with no heart murmur or history of valve replacement, stenosis, regurgitation, or hypertrophic cardiomyopathy |
| Left ventricular assist device patients | Patients with previously implanted LVAD |
| Renal dialysis patients | Patients on hemodialysis, peritoneal dialysis, or chronic kidney disease with dialysis fistula to be created. |
|
| D014694 |
| Ventricular Outflow Obstruction |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |