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

Study Overview
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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.

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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: CADence


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AMBIENCE<br>CADence System testing followed by coronary angiogram | Device: CADence<br> <br> |
| AMBIENCE plus R&R Substudy<br>CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram | Device: CADence<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate | Angiographically significant stenosis was defined as 70% or greater stenosis in any major coronary artery. Percent of Participants with Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as accurate and appropriate. The study is used to determine two conditions. CADence = Positive for 70% or greater stenosis and CADence = Negative for less than 70% stenosis. The pre-specified intent of this Outcome Measure was to assess all study participants combined, irrespective of whether or not they participated in the Ambience main study or the repeatability and reproducibility sub-study. | 24 hours or discharge from hospital, whichever is sooner | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With CADence-related Adverse Events |  | 24 hours or discharge from hospital, whichever is sooner |