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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CADence

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 Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects already scheduled for coronary angiography who meet study inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AMBIENCE; CADence System testing followed by coronary angiogram	Device: CADence
AMBIENCE plus R&R Substudy; CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram	Device: CADence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours or discharge from hospital, whichever is sooner

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AUM Cardiovascular, Inc.
• Investigators: Study Chair: Carmelo Panetta, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 1217-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes