Trials / Unknown
UnknownNCT04562142
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 395 (estimated)
- Sponsor
- AusculSciences Canada Inc. · Industry
- Sex
- All
- Age
- 19 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.
Detailed description
This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CAD-det | CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site. |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2022-03-01
- Completion
- 2022-05-01
- First posted
- 2020-09-24
- Last updated
- 2020-09-24
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04562142. Inclusion in this directory is not an endorsement.