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NCT01090947 Clinical Trial

Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Coronary Artery Disease Clinical Trial

Official title:
Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01090947
Other study ID # CP002IN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date March 2011

Study information
Verified date March 2019
Source Acarix
Contact n/a
Is FDA regulated No
Health authority
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 suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Recruitment information / eligibility
Status Completed
Enrollment 729
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• ProtoCAD
Aquiring acoustic signals from heart patients.

Locations
Country Name City State
Denmark University Hospital of Copenhagen Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Acarix Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups. The first testday
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