Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm
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|ClinicalTrials.gov Identifier: NCT01564628|
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: CADScor1|
|Study Type :||Observational|
|Actual Enrollment :||306 participants|
|Official Title:||Data Acquisition for Optimization of Coronary Artery Disease Algorithm|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
All study participants
Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).
- The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. [ Time Frame: Heart sound recordings measured on testday (25 minutes study period) ]
Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve.
The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values.
The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients.
CAD and non-CAD patients are defined by the CTA and CAG evaluations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564628
|University Hospital of Aarhus, Skejby|
|Aarhus N, Denmark, 8200|
|Principal Investigator:||Morten Bøttcher, MD||University Hospital of Aarhus, Skejby|