Clinical trial NCT01605669: Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
Official title: Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: Auscultation
Aortic stenosis
computer assisted auscultation
Aortic Stenosis Acceleration Index
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: 3M
name: The Geneva Foundation
First posted: 2012-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Aortic Stenosis seen in the internal medicine clinic at NMCSD

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: William E Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1161/01.cir.27.3.426. No abstract available.
citation: 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.
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. No abstract available.
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. doi: 10.1016/s0735-1097(96)00563-3.