Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03914079
Status:
SUSPENDED
Last Update Posted:
2021-01-12
First Post:
2019-01-31
Brief Title:
Evaluation of the CAD-det System a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
Sponsor:
AusculSciences Canada Inc
Organization:
AusculSciences Canada Inc
Study Overview
Official Title:
Evaluation of the CAD-det System a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
Status:
SUSPENDED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAD-det
Brief Summary:
The primary purpose of this multi-center study is to collect and study the acoustic and electrical signals created by the heart during the cardiac cycle as a result of stenosis or plaque associated with coronary artery disease CAD
Detailed Description:
This research intends to evaluate acoustic and electrical cardiovascular signals in patients with known or suspected CAD and establish the ability of the CAD-det System to accurately and reliably detect them utilizing coronary computed tomography CCTA and invasive coronary angiography ICA as reference standards In addition this study will collect clinical and acoustic data of other cardiac pathologies to better understand their impact on the acoustic signatures associated with 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