Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Acarix

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: ProtoCAD

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01090947

CP002IN

Details and patient eligibility

About

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

Full description

Acoustic information from the heart is obtained from patients suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Enrollment: 729 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age minimum 18 years
• Referred to CAG on suspicion of CAD
• Stabile angina without ACS
• Signed informed consent

Exclusion criteria

• ACS
• Previous bypass operation
• Previous heart transplant(incl. mechanical or artificial)
• Pregnancy
• Damaged skin on examination location

Trial design

729 participants in 1 patient group

Patients referred to CAG.

Description:

Sequential design with ProtoCAD and CAG

Treatment:

Device: ProtoCAD