Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease

Validation of the Cardiosond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CardioSond Cardiac Sonospectrographic Analyzer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will be sourced from patients presenting themselves for cardiac CT angiography who meet appropriate inclusion / exclusoin criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac CT; All patients in the study will be those presenting themselves for cardiac CT angiography who meet the proper inclusion / exclusion criteria	Device: CardioSond Cardiac Sonospectrographic Analyzer; The CardioSond is a completely noninvasive, FDA 510(k) cleared digital electronic stethoscope designed to detect heart sounds and murmurs using ultrasensitive acoustic technology.; Other Names: CSA; CardioSond

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: SonoMedica, Inc.
• Collaborators: Northwell Health; North Shore University Hospital
• Investigators: Principal Investigator: Amgad N Makaryus, MD, North Shore University Hospital; Study Director: Diane Dellilune, RN, North Shore University Hospital

Publications and helpful links

Helpful Links

• North Shore University Hospital website

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 29, 2009
• First Submitted That Met QC Criteria: December 29, 2009
• First Posted (Estimate): December 30, 2009

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Diagnostic; CAD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SM-C102