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

AUM Cardiovascular

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: CADence

Study type

Observational

Funder types

Industry

Identifiers

NCT02515825

1217-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

101 patients

Sex

All

Ages

41+ years old

Volunteers

No Healthy Volunteers

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