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

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

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.

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.

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