Coronary Artery DiseaseNCT01374555
Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by SonoMedica, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2010to 27 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be sourced from patients presenting for cardiac CT angiography who meet inclusion / exclusion criteria.
Who may be able to join
- Willingness to sign an informed consent.
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975
About this study
Official title: Validation of the CardioSond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography
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).
Read the 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
- Keywords
- Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study start29 Sep 2010
- Primary completion27 Apr 2011
- Study completion27 Apr 2011
Why it stopped: Inconsistent data taken from Phase I cohort
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- SonoMedica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Allen J. Taylor, M.D., Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374555
- Sponsor's protocol ID
- SM-C103
- Other IDs
- 2010-153
- Status last verified
- Feb 2013
- First submitted
- 14 Jun 2011
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the CardioSond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography
- ClinicalTrials.gov ID
- NCT01374555
- Acronym / sponsor ID
- SM-C103
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inconsistent data taken from Phase I cohort
- Enrolment
- 107 participants (actual)
- Lead sponsor
- SonoMedica, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Study start
- 29 Sep 2010 (actual)
- Primary completion
- 27 Apr 2011 (actual)
- Study completion
- 27 Apr 2011 (actual)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be sourced from patients presenting for cardiac CT angiography who meet inclusion / exclusion criteria.
Key inclusion criteria (1 listed)
- Willingness to sign an informed consent.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: Inconsistent data taken from Phase I cohort). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen J. Taylor, M.D. principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by SonoMedica, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inconsistent data taken from Phase I cohort). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.