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NCT03458806 · ClinicalTrials.gov registry record
Phono- and Electrocardiogram Assisted Detection of Valvular Disease
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 156
- Enrollment target
NCT03458806: Completed study, sponsored by University of California, San Francisco.
NCT03458806 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 156 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03458806 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 156 participants
- Enrollment target
Study Summary
The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to life-saving therapies and reduce the need for costly testing. The FDA-approved Eko Duo device consists of a digital stethoscope and a single-lead electrocardiogram (ECG), which wirelessly pairs with the Eko Mobile application to allow for simultaneous recording and visualization of phono- and electrocardiograms. These features uniquely situate this device to accumulate large sets of auscultatory data on patients both with and without VHD. In this study, the investigators seek to develop an automated system to identify VHD by phono- and electrocardiogram. Specifically, the investigators will attempt to develop machine learning algorithms to learn the phonocardiograms of patients with clinically important aortic stenosis (AS) or mitral regurgitation (MR), and then task the algorithms to identify subjects with clinically important VHD, as identified by a gold standard, from naïve phonocardiograms. The investigators anticipate that the study has the potential to revolutionize the diagnosis of VHD by providing a more accurate substitute to traditional auscultation.
Primary Outcome
Identification by the trained machine learning algorithm of clinically important aortic stenosis (defined as moderate-to-severe or greater) from control subjects with structurally normal hearts and no greater than mild valvular heart disease, with comparison to the gold standard echocardiogram interpretation. As our algorithm will provide a continuous "score" to determine the likelihood of disease, the data will primarily come in the form of a receiver operating characteristic curve, for which w
Interventions
- DIAGNOSTIC_TEST AS Algorithm 1
- DIAGNOSTIC_TEST AS Algorithm 2
- DIAGNOSTIC_TEST MR Algorithm 1
- DIAGNOSTIC_TEST MR Algorithm 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2019-11-11 |
What the finished NCT03458806 record still lists
NCT03458806 is an observational study that tracks outcomes without assigning an intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which AS Algorithm 1 is the first listed.
NCT03458806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03458806 about?
NCT03458806 is a clinical study titled "Phono- and Electrocardiogram Assisted Detection of Valvular Disease". The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to life-saving therapies and reduce the need for costly testing. The FDA-approved ...
What is the current status of trial NCT03458806?
This trial is currently completed. The enrollment target is 156 participants. The study started on 2018-02-22. Estimated completion is 2019-11-11.
What interventions are being tested in trial NCT03458806?
The interventions under investigation include: AS Algorithm 1 (DIAGNOSTIC_TEST), AS Algorithm 2 (DIAGNOSTIC_TEST), MR Algorithm 1 (DIAGNOSTIC_TEST), MR Algorithm 2 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03458806?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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