Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)

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

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-06-30

Brief Summary

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This is a prospective, multi-center study to capture information on sensitivity and specificity of CADence using coronary angiogram as the gold standard, on subjects who are already scheduled for coronary angiography.

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Detailed Description

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CADence is an ECG and acoustic tool to assess coronary artery disease. This study's goal is to collect patient CADence information and compare it to the results of angiogram to determine performance: sensitivity and specificity. The CADence is not used to direct patient care. This is observational only.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AMBIENCE

CADence System testing followed by coronary angiogram

CADence

Intervention Type DEVICE

AMBIENCE plus R&R Substudy

CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram

CADence

Intervention Type DEVICE

Interventions

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CADence

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>40 years
* Clinical indication for coronary angiogram
* Willing and able to give informed consent

Exclusion Criteria

* Body Mass Index (BMI) \<18.5 or \>40
* Prior bypass surgery or coronary stenting
* Presence of pacemaker/defibrillator
* Presence of artificial valve
* Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta
* Presence of murmurs, including valve lesions, ventricular septal defects and arteriovenous fistulae
* Presence of moderate-severe valve disease
* Left Ventricular Assist Device (LVAD)
* Presence of scars on the site thorax areas
* Participation in trial within 30 days prior to collecting CADence data except participation in registry studies.
* Asthma or chronic obstructive pulmonary disease (COPD) with active wheezing
* Inability to lie in supine position
* Heart Transplant

Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No