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

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02515825

Run by

AUM Cardiovascular, Inc.

People needed

101

Starts

2016-05-01

Expected to finish

2016-06-01

Last updated by the study team

2021-04-08

Who can join

Age: 41 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• St. Joseph's Hospital — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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