Brief Title
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
Official Title
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
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.
Study Type
Observational
Primary Outcome
Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
Condition
Aortic Stenosis
Intervention
Tranthoracic Echocardiogram
Study Arms / Comparison Groups
Aortic stenosis patients
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
50
Start Date
May 2012
Completion Date
June 2013
Primary Completion Date
June 2013
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
William E Bennett, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01605669
Organization ID
NMCSD.2011.0123
Responsible Party
Sponsor
Study Sponsor
United States Naval Medical Center, San Diego
Collaborators
3M
Study Sponsor
William E Bennett, MD, Principal Investigator, United States Naval Medical Center, San Diego
Verification Date
August 2016