Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01090947

Enrollment

729

Registered

2010-03-23

Start date

2010-03-31

Completion date

2011-03-31

Last updated

2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEProtoCAD

Aquiring acoustic signals from heart patients.

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026