Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease

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 post CT angiography.

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.

Inclusion Criteria:

- Willingness to sign an informed consent.

Exclusion Criteria:

- Inability to provide informed consent

- History of prior myocardial infarction, percutaneous coronary intervention (i.e.
stents) or coronary artery bypass graft surgery

- Heart rate over 70 beats per minute post beta blockade

- Artery calcification resulting in non-diagnostic CT angiographic images

- Supraventricular or ventricular arrhythmias that would be expected to affect CT
angiography image quality (e.g. atrial fibrillation, atrial flutter, ventricular
tachycardia, bigeminy and trigeminy). Patients with isolated premature atrial
contraction and premature ventricular contractions may enroll

- Any pulmonary condition that would create abnormal physical findings that would
interfere with the fidelity of the cardiac sound recordings (e.g. obstructive
pulmonary disease, such as asthma or COPD, with audible wheezing)

- Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow
diastolic murmurs or continuous murmurs

- Any chest wall configuration preventing adequate contact between the CardioSond
acoustic recording sensor and precordium

- Any medical condition that would be expected to affect CT angiography image quality