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

This study has been completed.
Sponsor:
Collaborators:
North Shore University Hospital
North Shore Long Island Jewish Health System
Information provided by:
SonoMedica, Inc.
ClinicalTrials.gov Identifier:
NCT01040923
First received: December 29, 2009
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention
Coronary Artery Disease
 Device: CardioSond Cardiac Sonospectrographic Analyzer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation of the Cardiosond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SonoMedica, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Post collection of CardioSond and CT angiography data ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Upon collection of CardioSond and CT angiography data ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • CardioSond
  • CSA

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040923

Locations
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
SonoMedica, Inc.
North Shore University Hospital
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Amgad N Makaryus, MD North Shore University Hospital
Study Director: Diane Dellilune, RN North Shore University Hospital
  More Information

Additional Information:
North Shore University Hospital website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michael Lahr / President and Chief Operating Officer, SonoMedica, Inc.
ClinicalTrials.gov Identifier: NCT01040923     History of Changes
Other Study ID Numbers: SM-C102
Study First Received: December 29, 2009
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by SonoMedica, Inc.:
CAD
Diagnostic

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 May 22, 2013