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

This study has suspended participant recruitment.
(Phase II cohort recruitment suspended until analysis of Phase I cohort completed)
Sponsor:
Collaborators:
Washington Hospital Center
Medstar Research Institute
Information provided by (Responsible Party):
SonoMedica, Inc.
ClinicalTrials.gov Identifier:
NCT01374555
First received: June 14, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the CardioSond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography

Resource links provided by NLM:


Further study details as provided by SonoMedica, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Determine the effects of vasodilators and beta blockade on CardioSond digital electronic stethoscope data results on data taken post CT angiography. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The patient's flow micro bruit scores from each CardioSond examination (one pre CT angiography and one post CT angiography) will be compared to each other to assess the effects on the score of vasodilators administered as part of the CT angiography exam.


Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374555

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010-2975
Sponsors and Collaborators
SonoMedica, Inc.
Washington Hospital Center
Medstar Research Institute
Investigators
Principal Investigator: Allen J. Taylor, M.D. Washington Hospital Center
  More Information

No publications provided

Responsible Party: SonoMedica, Inc.
ClinicalTrials.gov Identifier: NCT01374555     History of Changes
Other Study ID Numbers: SM-C103, 2010-153
Study First Received: June 14, 2011
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by SonoMedica, Inc.:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014