Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (Cassette)

This study has been completed.
Sponsor:
Collaborators:
3M
The Geneva Foundation
Information provided by (Responsible Party):
William E Bennett, MD FACC, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01605669
First received: May 17, 2012
Last updated: November 1, 2013
Last verified: November 2013

May 17, 2012
November 1, 2013
May 2012
November 2012   (final data collection date for primary outcome measure)
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.
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 arotic valve area derived from the continuity equation.
Complete list of historical versions of study NCT01605669 on ClinicalTrials.gov Archive Site
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Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with Aortic Stenosis seen in the internal medicine clinic at NMCSD

Aortic Stenosis
  • Other: Tranthoracic Echocardiogram
  • Other: Cardiac Ascultation Recordings with Electronic stethoscope
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.
Interventions:
  • Other: Tranthoracic Echocardiogram
  • Other: Cardiac Ascultation Recordings with Electronic stethoscope

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605669
NMCSD.2011.0123
No
William E Bennett, MD FACC, United States Naval Medical Center, San Diego
United States Naval Medical Center, San Diego
  • 3M
  • The Geneva Foundation
Principal Investigator: William E Bennett, MD United States Naval Medical Center, San Diego
United States Naval Medical Center, San Diego
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP