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

NCT02515825 | Completed Results FDA Device

• 1 other identifier: 1217-001
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With CADence-related Adverse Events

  24 hours or discharge from hospital, whichever is sooner

Study Arms (2)

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

Interventions

CADence DEVICE

AMBIENCE; AMBIENCE plus R&R Substudy

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \>40 years
• Clinical indication for coronary angiogram
• Willing and able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• AUM Cardiovascular, Inc.: lead

Study Sites (3)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Marie Johnson, PhD
• Organization: AUM Cardiovascular

mariej@aumcv.com

612.799.2511

Study Officials

• Carmelo Panetta, MD

  University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 8, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)