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 accuracy of the CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD) in patients with and without known disease who are referred to cardiac computed tomography angiography (CT scans).
The CardioSond is a noninvasive medical device which detects heart sounds 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 two times: once prior to administration of
vasodilators and potential beta blockade agents as part of the normal cardiac CT angiography
protocol and again immediately post CT angiography. No other data will be taken on the
patient and the patients involvement in the study will cease after data collection.
CT angiography data will be analyzed at a core lab at Medstar Research Institute and withheld
from SonoMedica until all CardioSond acoustic data is analyzed and flow micro bruit scores
are determined.
A data review panel lead by the principal investigator will examine the results of both the
CardioSond and CT angiography data to determine the comparative accuracy of the CardioSond in
detecting CAD in the study population.
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