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

Status

Completed

Conditions

Intervention / Treatment

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • University Hospital of Copenhagen

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
Patients referred to CAG.
Sequential design with ProtoCAD and CAG
Device: ProtoCAD
Aquiring acoustic signals from heart patients.
Other Names:
  • Acarix CAD device.

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
The first testday

Secondary Outcome Measures

Outcome Measure
Time Frame
Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups.
Time Frame: The first testday
The first testday

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acarix

Collaborators

Rigshospitalet, Denmark

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.

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