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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Acarix
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01564628
First received: March 21, 2012
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).


Condition Intervention
Coronary Artery Disease
Device: Acoustic recording. *CAD Patch System' Prototype no. 3.0. Manufactured by Acarix A/S, Denmark

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Data Acquisition for Optimization of Coronary Artery Disease Algorithm

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Cardiac noise marker [ Time Frame: Heart sound recordings measured on testday (25 minutes study period) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Sub-group cardiac noise marker [ Time Frame: Heart sound recordings measured on testday (25 minutes study period) ] [ Designated as safety issue: No ]
    Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups.


Estimated Enrollment: 250
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy
Healthy subjects without previous heart disease
Device: Acoustic recording. *CAD Patch System' Prototype no. 3.0. Manufactured by Acarix A/S, Denmark
Moderate to severe stenosis
Patients with moderate to severe stenosis
Device: Acoustic recording. *CAD Patch System' Prototype no. 3.0. Manufactured by Acarix A/S, Denmark
Previously diagnosed patients
Patients with previous MI and/or CAD diagnosis leading to stenting
Device: Acoustic recording. *CAD Patch System' Prototype no. 3.0. Manufactured by Acarix A/S, Denmark

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564628

Locations
Denmark
University Hospital of Aarhus, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Coloplast A/S
Acarix
Investigators
Principal Investigator: Morten Bøttcher, MD University Hospital of Aarhus, Skejby
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01564628     History of Changes
Other Study ID Numbers: AC003-SH
Study First Received: March 21, 2012
Last Updated: March 26, 2012
Health Authority: Denmark: The National Committee on Health Research Ethics
Denmark: Danish Medicines Agency

Keywords provided by Coloplast A/S:
CAD

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

ClinicalTrials.gov processed this record on July 29, 2014