Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease
|Coronary Artery Disease||Device: CardioSond Cardiac Sonospectrographic Analyzer|
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Validation of the Cardiosond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography|
- Comparison of the CardioSond digital electronic stethoscope's flow micro bruit score as an indication of the probability of coronary artery disease in patients without know disease versus the results of cardiac CT angiography. [ Time Frame: Post collection of CardioSond and CT angiography data ]
- Comparison of CardioSond's flow micro bruit score as an indication of the probability of coronary artery disease against the results of cardiac CT angiography in patient subgroups including age, sex, body mass index, location and severity of disease. [ Time Frame: Upon collection of CardioSond and CT angiography data ]
|Study Start Date:||January 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
All patients in the study will be those presenting themselves for cardiac CT angiography who meet the proper inclusion / exclusion criteria
Device: CardioSond Cardiac Sonospectrographic Analyzer
The CardioSond is a completely noninvasive, FDA 510(k) cleared digital electronic stethoscope designed to detect heart sounds and murmurs using ultrasensitive acoustic technology.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040923
|United States, New York|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|Principal Investigator:||Amgad N Makaryus, MD||North Shore University Hospital|
|Study Director:||Diane Dellilune, RN||North Shore University Hospital|