Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

NCT ID: NCT01605669

Last Updated: 2016-09-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every 1-2 years for moderate disease and every 3-5 years for mild disease. This results in a multitude of screening studies in the investigators patient population. 3M has developed a new stethoscope and phonocardiography software capable of identifying the peak intensity of the AS murmur and tracking it as it moves towards the second heart sound potentially indicating increasing severity of disease. Currently there exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates to disease severity or progression of disease. The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. In this study the investigators propose to correlate the ASAI to standard TTE measurements of aortic stenosis severity.

Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic stenosis patients

Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study. All participants will recieve a transthoracic echocardiogram and recorded cardiac auscultation.

Tranthoracic Echocardiogram

Intervention Type OTHER

standard measurement

Cardiac Ascultation Recordings with Electronic stethoscope

Intervention Type DEVICE

3M device

Interventions

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Tranthoracic Echocardiogram

standard measurement

Intervention Type OTHER

Cardiac Ascultation Recordings with Electronic stethoscope

3M device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects 18 years of age and older.
2. Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
3. Subjects must be able to sit for auscultation examination.
4. Subject must be able to complete a TTE .
5. Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.

Exclusion Criteria

1. Subjects with significant additional valvular heart disease.
2. Subjects with unrecordable heart sounds.
3. Subjects with known or who may have been previously diagnosed with congenital heart disease.
4. Subjects with atrial fibrillation.
5. Subjects with history of cardiac surgery.
6. Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

The Geneva Foundation

OTHER

Sponsor Role collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William E Bennett, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

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Naval Medical Center San Diego

San Diego, California, United States

Site Status

Countries

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United States

References

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BRAUNWALD E, GOLDBLATT A, AYGEN MM, ROCKOFF SD, MORROW AG. Congenital aortic stenosis. I. Clinical and hemodynamic findings in 100 patients. II. Surgical treatment and the results of operation. Circulation. 1963 Mar;27:426-62. doi: 10.1161/01.cir.27.3.426. No abstract available.

Reference Type BACKGROUND
PMID: 14015087 (View on PubMed)

Bonner AJ Jr, Sacks HN, Tavel ME. Assessing the severity of aortic stenosis by phonocardiography and external carotid pulse recordings. Circulation. 1973 Aug;48(2):247-52. doi: 10.1161/01.cir.48.2.247. No abstract available.

Reference Type BACKGROUND
PMID: 4726205 (View on PubMed)

Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26. No abstract available.

Reference Type BACKGROUND
PMID: 18820172 (View on PubMed)

Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3.

Reference Type BACKGROUND
PMID: 9060903 (View on PubMed)

Other Identifiers

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NMCSD.2011.0123

Identifier Type: -

Identifier Source: org_study_id

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