- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01605669
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (Cassette)
August 17, 2016 updated by: United States Naval Medical Center, San Diego
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92134
- Naval Medical Center San Diego
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Aortic Stenosis seen in the internal medicine clinic at NMCSD
Description
Inclusion Criteria:
- Male and female subjects 18 years of age and older.
- Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
- Subjects must be able to sit for auscultation examination.
- Subject must be able to complete a TTE .
- Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.
Exclusion Criteria:
- Subjects with significant additional valvular heart disease.
- Subjects with unrecordable heart sounds.
- Subjects with known or who may have been previously diagnosed with congenital heart disease.
- Subjects with atrial fibrillation.
- Subjects with history of cardiac surgery.
- Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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standard measurement
3M device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
Time Frame: 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.
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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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William E Bennett, MD, United States Naval Medical Center, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
May 17, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (ESTIMATE)
May 25, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 23, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2011.0123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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