Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Aortic Stenosis Clinical Trial

— Cassette  

Official title:

Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605669
• Other study ID #: NMCSD.2011.0123
• Status: Completed
• Phase: N/A
• First received: May 17, 2012
• Last updated: November 1, 2013
• Start date: May 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• Tranthoracic Echocardiogram

• Cardiac Ascultation Recordings with Electronic stethoscope

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	3M, The Geneva Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity	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. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.	There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.	No