Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01040923
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2009-12-29
Brief Title:
Comparison of Digital Electronic Stethoscope to Computed Tomography CT Angiography in Detection of Coronary Artery Disease
Sponsor:
SonoMedica Inc
Organization:
SonoMedica Inc
Study Overview
Official Title:
Validation of the Cardiosond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
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 study is designed to evaluate the predictive diagnostic accuracy of SonoMedicas CardioSond digital electronic stethoscope in the detection of coronary artery disease CAD in patients without known disease who are referred to cardiac computed tomography angiography CT scans
Detailed Description:
The CardioSond is a completely noninvasive medical device which detects heart sounds and murmurs using ultrasensitive acoustic technology The CardioSond produces a flow micro bruit score which is used to determine the likelihood of coronary artery disease
The CardioSond exam will be given to patients who agree to participate in the study upon signing of an informed consent form and prior to the administration of beta blocker agents and or vasodilators as part of the normal cardiac CT angiography protocol
CardioSond data will be sent to an independent acoustic core lab which will determine data quality and produce a flow micro bruit score CT angiography data will be analyzed by staff at North Shore University Hospital
A data review panel lead my the principal investigator will examine the results of both the CardioSond and CT angiography data to determine the accuracy of the CardioSond in detecting CAD in the study population at large and in specific patient subgroups
The CardioSond exam will be given to patients who agree to participate in the study upon signing of an informed consent form and prior to the administration of beta blocker agents and or vasodilators as part of the normal cardiac CT angiography protocol
CardioSond data will be sent to an independent acoustic core lab which will determine data quality and produce a flow micro bruit score CT angiography data will be analyzed by staff at North Shore University Hospital
A data review panel lead my the principal investigator will examine the results of both the CardioSond and CT angiography data to determine the accuracy of the CardioSond in detecting CAD in the study population at large and in specific patient subgroups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None