Coronary Artery Disease Clinical Trial
Official title:
Validation of the Cardiosond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography
The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's 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).
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.
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