Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: ProtoCAD

• Registration Number: NCT01090947
• Lead Sponsor: Acarix

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 suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-23
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 729

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients referred to CAG.	ProtoCAD	Sequential design with ProtoCAD and CAG

Primary Outcome Measures

Name	Time	Method
Sensitivity versus 1-specificity as a function of cut-off values on the 'Cardiac Noise Marker' scale here under Sensitivity by suitable cut-off value on the 'Cardiac Noise Marker' scale and Specificity with same cut-off value.	The first testday

Secondary Outcome Measures

Name	Time	Method
Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups.	The first testday

Trial Locations

Locations (1)

University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark