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

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
All study participants	CADScor1	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).

Primary Outcome Measures

Name	Time	Method
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.	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.

Secondary Outcome Measures