Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease
Launched by SONOMEDICA, INC. · Dec 29, 2009
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect Summary
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 dete...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects who are undergoing routine screening coronary CT angiography
- • Willingness to sign informed consent form
- Exclusion Criteria:
- • Inability to provide informed consent form
- • Age less than 21 years
- • Any contraindications to coronary CT angiography
- • Known atherosclerotic heart disease, including a history of prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery or an established diagnosis of CAD by prior X-ray or CT angiography
- • 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 contractions and premature ventricular contractions may enroll.
- • Use of intravenous vasodilators
- • Any pulmonary conditions that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recording (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
About Sonomedica, Inc.
Sonomedica, Inc. is a pioneering clinical trial sponsor dedicated to advancing medical innovation through the development and commercialization of cutting-edge diagnostic and therapeutic solutions. With a strong emphasis on enhancing patient outcomes, Sonomedica leverages state-of-the-art technology and rigorous scientific methodologies to design and implement clinical trials that address unmet medical needs. The company's commitment to ethical practices and collaboration with healthcare professionals ensures the highest standards of quality and integrity in its research initiatives, positioning Sonomedica as a leader in the field of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Manhasset, New York, United States
Patients applied
Trial Officials
Amgad N Makaryus, MD
Principal Investigator
North Shore University Hospital
Diane Dellilune, RN
Study Director
North Shore University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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