Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (Cassette)
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.
Other: Tranthoracic Echocardiogram
Other: Cardiac Ascultation Recordings with Electronic stethoscope
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography|
- 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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
|Other: Tranthoracic Echocardiogram Other: Cardiac Ascultation Recordings with Electronic stethoscope|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605669
|United States, California|
|Naval Medical Center San Diego|
|San Diego, California, United States, 92134|
|Principal Investigator:||William E Bennett, MD||United States Naval Medical Center, San Diego|