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

NCT01564628 | Completed Results

• 1 other identifier: AC003-SH
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

CAD

Outcome Measures

Primary Outcomes (1)

• The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.

  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)

Study Arms (1)

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

Interventions

CADScor1 DEVICE

Acoustic recording

All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to examination for Coronary Artery Disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acarix: lead

Study Sites (1)

University Hospital of Aarhus, Skejby

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Claus Christensen
• Organization: Acarix A/S

dkcbc@acarix.com

+45 29724411

Study Officials

• Morten Bøttcher, MD

  University Hospital of Aarhus, Skejby

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 28, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-07

Locations

DK (1)