N/A Completed N=101

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

Coronary Artery Disease

Source: ClinicalTrials.gov NCT02515825 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcomePrimary: 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

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.