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

NCT01374555 | Terminated

• 2 other identifiers: SM-C1032010-153
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

Secondary Outcomes (1)

• Determine the effects of vasodilators and beta blockade on CardioSond digital electronic stethoscope data results on data taken post CT angiography.

  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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be sourced from patients presenting for cardiac CT angiography who meet inclusion / exclusion criteria.

You may qualify if:

• Willingness to sign an informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• SonoMedica, Inc.: lead
• Medstar Health Research Institute: collaborator

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010-2975, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Allen J. Taylor, M.D.

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 16, 2011
• Study Start: September 29, 2010
• Primary Completion: April 27, 2011
• Study Completion: April 27, 2011
• Last Updated: April 18, 2018

Record last verified: 2013-02

Locations

US (1)