Data Aquisition for Optimization of Coronary Artery Disease Algorithm
March 14, 2019 updated by: Acarix
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).
Study Overview
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
Observational
Enrollment (Actual)
729
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100
- University Hospital of Copenhagen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred to CAG.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients referred to CAG.
Sequential design with ProtoCAD and CAG
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Aquiring acoustic signals from heart patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: The first testday
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The first testday
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups.
Time Frame: The first testday
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The first testday
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Clemmensen, MD, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
March 18, 2010
First Submitted That Met QC Criteria
March 19, 2010
First Posted (Estimate)
March 23, 2010
Study Record Updates
Last Update Posted (Actual)
March 15, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP002IN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.