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

Coronary Artery Disease Clinical Trial

Official title:

Data Acquisition for Optimization of Coronary Artery Disease Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564628
• Other study ID #: AC003-SH
• Status: Completed
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2019
• Source: Acarix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CADScor1
Acoustic recording

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus, Skejby	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Acarix

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Heart sound recordings measured on testday (25 minutes study period)