Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04562142
Status:
UNKNOWN
Last Update Posted:
2020-09-24
First Post:
2020-09-18
Brief Title:
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
Sponsor:
AusculSciences Canada Inc
Organization:
AusculSciences Canada Inc
Study Overview
Official Title:
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
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients indication for CAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None