Coronary Artery Disease
Conditions
Keywords
CAD
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.
Interventions
DEVICECADScor1
Acoustic recording
Sponsors
Acarix
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 298 |
| Total | 298 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Denmark | 298 participants |
| Sex: Female, Male Female | 138 Participants |
| Sex: Female, Male Male | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 298 |
| other Total, other adverse events | 0 / 298 |
| serious Total, serious adverse events | 0 / 298 |
Outcome results
Primary
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.
Time frame: Heart sound recordings measured on testday (25 minutes study period)
Population: Per protocol analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Study Participants | The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. | 73.4 percentage of 100 |