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| Name | Class |
|---|---|
| North Shore University Hospital | OTHER |
| Northwell Health | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac CT | All patients in the study will be those presenting themselves for cardiac CT angiography who meet the proper inclusion / exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioSond Cardiac Sonospectrographic Analyzer | Device | The CardioSond is a completely noninvasive, FDA 510(k) cleared digital electronic stethoscope designed to detect heart sounds and murmurs using ultrasensitive acoustic technology. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post collection of CardioSond and CT angiography data |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Upon collection of CardioSond and CT angiography data |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will be sourced from patients presenting themselves for cardiac CT angiography who meet appropriate inclusion / exclusoin criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Amgad N Makaryus, MD | North Shore University Hospital | Principal Investigator |
| Diane Dellilune, RN | North Shore University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |