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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

41 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Research, LLC, Huntsville, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CADence

Device

Primary outcomes

Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate

Time frame: 24 hours or discharge from hospital, whichever is sooner

Angiographically significant stenosis was defined as 70% or greater stenosis in any major coronary artery. Percent of Participants with Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as accurate and appropriate. The study is used to determine two conditions. CADence = Positive for 70% or greater stenosis and CADence = Negative for less than 70% stenosis. The pre-specified intent of this Outcome Measure was to assess all study participants combined, irrespective of whether or not they participated in the Ambience main study or the repeatability and reproducibility sub-study.

Secondary outcomes

Number of Participants With CADence-related Adverse Events

Time frame: 24 hours or discharge from hospital, whichever is sooner

Sponsors and collaborators

Lead sponsor

AUM Cardiovascular, Inc.

Industry

Registry information

Acronym: AMBIENCE

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Aug 5, 2015
Registry last updated: Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed