N/A
N=101
Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02515825 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate — 101; 31 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CADence (Device)
- Age
- Adult, Older Adult · 41+ yrs
- Sex
- All
- Sponsor
- AUM Cardiovascular, Inc.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate |
101; 31 | — |
| SECONDARY Number of Participants With CADence-related Adverse Events |
0; 101 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age >40 years
- Clinical indication for coronary angiogram
- Willing and able to give informed consent
Exclusion Criteria
- Body Mass Index (BMI) 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
Data sourced from ClinicalTrials.gov (NCT02515825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.