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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

CADScor1

Intervention Type DEVICE

Acoustic recording

Interventions

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CADScor1

Acoustic recording

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No