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NCT01605669 · ClinicalTrials.gov registry record
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
A clinical trial, sponsored by United States Naval Medical Center, San Diego.
- Completed
- Registry status
- 50
- Enrollment target
NCT01605669: Completed study, sponsored by United States Naval Medical Center, San Diego.
NCT01605669 is a clinical trial that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605669 has completed, sponsored by United States Naval Medical Center, San Diego.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
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 f
Interventions
- OTHER Tranthoracic Echocardiogram
- DEVICE Cardiac Ascultation Recordings with Electronic stethoscope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-06 |
What the finished NCT01605669 record still lists
NCT01605669 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Tranthoracic Echocardiogram is the first listed.
NCT01605669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01605669 about?
NCT01605669 is a clinical study titled "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. Thi...
What is the current status of trial NCT01605669?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2012-05. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01605669?
The interventions under investigation include: Tranthoracic Echocardiogram (OTHER), Cardiac Ascultation Recordings with Electronic stethoscope (DEVICE).
Who is sponsoring clinical trial NCT01605669?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
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