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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Aarhus, Skejby

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CADScor1

Device

Acoustic recording

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Acarix

Industry

Registry information

Official study title

Data Acquisition for Optimization of Coronary Artery Disease Algorithm

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 28, 2012
Registry last updated: Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed