Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease

NCT ID: NCT01374555

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-29
• Study Completion Date: 2011-04-27

Brief Summary

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).

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

SonoMedica, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allen J. Taylor, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2010-153

Identifier Type: OTHER

Identifier Source: secondary_id

SM-C103

Identifier Type: -

Identifier Source: org_study_id