Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
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).
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Validation of the CardioSond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography|
- Determine the comparative diagnostic accuracy of the CardioSond digital electronic stethoscope versus CT angiography in detecting CAD, as defined as a stenosis of a major epicardial coronary artery of 50% or greater. [ Time Frame: Patient participation will be limited to the day of their CT angiography exam (day 1). Patients will receive two seperate CardioSond examinations which on average takes approximately 20 minutes. ] [ Designated as safety issue: No ]The CardioSond digital electronic stethoscope's flow micro bruit score will be used as an indication of probability of disease in patients with and without known disease and compared to the results of CT angiography.
- Determine the effects of vasodilators and beta blockade on CardioSond digital electronic stethoscope data results on data taken post CT angiography. [ Time Frame: Patient participation will be limited to the day of their CT angiography exam (day 1). Patients will receive two seperate CardioSond examinations which on averages takes approximately 20 minutes. ] [ Designated as safety issue: No ]The patient's flow micro bruit scores from each CardioSond examination (one pre CT angiography and one post CT angiography) will be compared to each other to assess the effects on the score of vasodilators administered as part of the CT angiography exam.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374555
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010-2975|
|Principal Investigator:||Allen J. Taylor, M.D.||Washington Hospital Center|