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
  Purpose

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.


Condition Intervention
Aortic Stenosis
Other: Tranthoracic Echocardiogram
Other: Cardiac Ascultation Recordings with Electronic stethoscope

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605669

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
3M
The Geneva Foundation
Investigators
Principal Investigator: William E Bennett, MD United States Naval Medical Center, San Diego
  More Information

Publications:
Responsible Party: William E Bennett, MD FACC, Prinicple Investigator, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01605669     History of Changes
Other Study ID Numbers: NMCSD.2011.0123
Study First Received: May 17, 2012
Results First Received: May 17, 2013
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
Auscultation
Aortic stenosis
computer assisted auscultation
Aortic Stenosis Acceleration Index

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014