Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm

July 15, 2019 updated by: Acarix

Data Acquisition for Optimization of Coronary Artery Disease Algorithm

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 referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Study Type

Observational

Enrollment (Actual)

306

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
      • Aarhus N, Denmark, 8200
        • University Hospital of Aarhus, Skejby

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 examination for Coronary Artery Disease

Description

Inclusion Criteria:

  • At least 18 years old
  • Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease
  • Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome
  • Subject is willing to adhere to the study procedure
  • Has signed the informed consent form and authorization to registration and publication of health information

Exclusion Criteria:

  • Has acute coronary syndrome or stroke
  • Arterial fibrillation
  • Known severe arrhythmia or resting heart rate above 85 bpm
  • Known diastolic murmurs due to heart valve disease
  • Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart
  • Reduced ejection fraction < 50%
  • Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma)
  • Inability to perform CT-angio and/or subsequent CAG
  • In active treatment for any cancer
  • In active treatment for immunosuppression after transplantation
  • Established or pursuing pregnancy or breast feeding
  • Has damaged skin on the spot where the patch is placed during the recordings.

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
All study participants
Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).
Device: CADScor1
Acoustic recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
Time Frame: Heart sound recordings measured on testday (25 minutes study period)

Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve.

The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values.

The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients.

CAD and non-CAD patients are defined by the CTA and CAG evaluations.
Heart sound recordings measured on testday (25 minutes study period)

Collaborators and Investigators

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

Sponsor

Acarix

Investigators

  • Principal Investigator: Morten Bøttcher, MD, University Hospital of Aarhus, Skejby

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, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC003-SH

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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