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

NCT01040923 | Completed

• 1 other identifier: SM-C102
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease

Keywords

CAD; Diagnostic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

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

Interventions

CardioSond Cardiac Sonospectrographic Analyzer DEVICE

The CardioSond is a completely noninvasive, FDA 510(k) cleared digital electronic stethoscope designed to detect heart sounds and murmurs using ultrasensitive acoustic technology.

Also known as: CardioSond, CSA

Cardiac CT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects who are undergoing routine screening coronary CT angiography
• Willingness to sign informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• SonoMedica, Inc.: lead
• North Shore University Hospital: collaborator
• Northwell Health: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amgad N Makaryus, MD

  North Shore University Hospital

  PRINCIPAL INVESTIGATOR

• Diane Dellilune, RN

  North Shore University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (1)