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Data Aquisition for Optimization of Coronary Artery Disease Algorithm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01090947
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Coronary Artery Disease Device: ProtoCAD

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 Design

Study Type : Observational
Actual Enrollment : 729 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Data Aquisition for Optimization of Coronary Artery Disease Algorithm
Study Start Date : March 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients referred to CAG.
Sequential design with ProtoCAD and CAG
Device: ProtoCAD
Aquiring acoustic signals from heart patients.
Other Name: Acarix CAD device.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups. [ Time Frame: The first testday ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to CAG.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090947


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

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01090947     History of Changes
Other Study ID Numbers: CP002IN
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases