Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Data Aquisition for Optimization of Coronary Artery Disease Algorithm

This study has been completed.
Rigshospitalet, Denmark
Information provided by:
Coloplast A/S Identifier:
First received: March 18, 2010
Last updated: May 10, 2011
Last verified: May 2011

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

Condition Intervention
Coronary Artery Disease
Device: Acoustic recording.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Resource links provided by NLM:

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 350
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients referred to CAG. Device: Acoustic recording.
Aquiring acoustic signals from heart patients.
Other Name: Acarix CAD device.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to CAG.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01090947

University Hospital of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Coloplast A/S
Rigshospitalet, Denmark
Principal Investigator: Peter Clemmensen, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Claus B.V. Christensen / Chief Operating Officer, Acarix A/S Identifier: NCT01090947     History of Changes
Other Study ID Numbers: CP002IN
Study First Received: March 18, 2010
Last Updated: May 10, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on March 03, 2015