Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm

Study Overview
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Brief Summary
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The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).

Detailed Description
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Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Official Title
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Data Acquisition for Optimization of Coronary Artery Disease Algorithm

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CADScor1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome Subject is willing to adhere to the study procedure Has signed the informed consent form and authorization to registration and publication of health information Exclusion Criteria: Has acute coronary syndrome or stroke Arterial fibrillation Known severe arrhythmia or resting heart rate above 85 bpm Known diastolic murmurs due to heart valve disease Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart Reduced ejection fraction < 50% Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma) Inability to perform CT-angio and/or subsequent CAG In active treatment for any cancer In active treatment for immunosuppression after transplantation Established or pursuing pregnancy or breast feeding Has damaged skin on the spot where the patch is placed during the recordings.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All study participants<br>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). | Device: CADScor1<br>* Acoustic recording<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. | 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. | Heart sound recordings measured on testday (25 minutes study period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD