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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: CADence

• Registration Number: NCT02515825
• Lead Sponsor: AUM Cardiovascular, Inc.

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-05
• Study Start: 2016-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2018-01-08
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-09
• Results First Posted: 2021-03-15
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMBIENCE plus R&R Substudy	CADence	CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram
AMBIENCE	CADence	CADence System testing followed by coronary angiogram

Primary Outcome Measures

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

Name	Time	Method
Number of Participants With CADence-related Adverse Events	24 hours or discharge from hospital, whichever is sooner

Trial Locations

Locations (3)

MedStar Union Memorial Hospital; 🇺🇸 Baltimore, Maryland, United States

St. Joseph's Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States