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Data Acquisition for Optimization of Coronary Artery Disease (CAD) 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: NCT01564628
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Acarix

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: CADScor1

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.

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Study Type : Observational
Actual Enrollment : 306 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Data Acquisition for Optimization of Coronary Artery Disease Algorithm
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to examination for Coronary Artery Disease
Criteria

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.

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): NCT01564628


Locations
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Denmark
University Hospital of Aarhus, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Acarix
Investigators
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Principal Investigator: Morten Bøttcher, MD University Hospital of Aarhus, Skejby
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Responsible Party: Acarix
ClinicalTrials.gov Identifier: NCT01564628    
Other Study ID Numbers: AC003-SH
First Posted: March 28, 2012    Key Record Dates
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019
Last Verified: July 2019
Keywords provided by Acarix:
CAD
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases