Performance of the Acoustic Based CADScor System in Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorINTEGRIS Baptist Medical Center
About this trial
The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed ICF
Male or female, aged 30 years or above
Symptoms suggestive of stable coronary artery disease
No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
Disqualifiers
None
Trial population
Subjects to be recruited from INTEGRIS Baptist Medical Center.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Acoustic Detection of Blood Flow
Diagnostic testSubject will have the acoustic device scoring performed prior to a Coronary CTA. No treatment decisions will be based upon the acoustic device score.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Objective
To determine that the sensitivity of the CAD score in low to intermediate-risk patients referred for coronary CTA in non-inferior to the device specified sensitivity at 89%.
Time frame
From enrollment through 1 yearSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: