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

Coronary Artery Disease Clinical Trial

— AMBIENCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515825
• Other study ID #: 1217-001
• Status: Completed
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: March 2021
• Source: AUM Cardiovascular, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• CADence

Locations

Country	Name	City	State
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Joseph's Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
AUM Cardiovascular, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With CADence-related Adverse Events		24 hours or discharge from hospital, whichever is sooner