- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01374555
Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Validation of the CardioSond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010-2975
- Washington Hospital Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Allen J. Taylor, M.D., MedStar Health Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM-C103
- 2010-153 (Other Identifier: Medstar Research Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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