Data Aquisition for Optimization of Coronary Artery Disease Algorithm

This study has been completed.

Sponsor:

Collaborator:

Rigshospitalet, Denmark

Information provided by:

Coloplast A/S

ClinicalTrials.gov Identifier:

NCT01090947

First received: March 18, 2010

Last updated: May 10, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 18, 2010

Last Updated Date

May 10, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: The first testday ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01090947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups. [ Time Frame: The first testday ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Official Title ^ICMJE

Data Aquisition for Optimization of Coronary Artery Disease Algorithm

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients referred to CAG.

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Device: Acoustic recording.

Aquiring acoustic signals from heart patients.

Other Name: Acarix CAD device.

Study Group/Cohort (s)

Patients referred to CAG.

Intervention: Device: Acoustic recording.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

350

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01090947

Other Study ID Numbers ^ICMJE

CP002IN

Has Data Monitoring Committee

Responsible Party

Claus B.V. Christensen / Chief Operating Officer, Acarix A/S

Study Sponsor ^ICMJE

Coloplast A/S

Collaborators ^ICMJE

Rigshospitalet, Denmark

Investigators ^ICMJE

Principal Investigator:

Peter Clemmensen, MD

Rigshospitalet, Denmark

Information Provided By

Coloplast A/S

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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