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

AUM Cardiovascular, Inc.101 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Coronary Artery Disease

Interventions

CADenceDEVICE

Eligibility

Sex: ALLMin age: 41 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

Number of Participants With CADence-related Adverse Events

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

Data from ClinicalTrials.gov

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