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

• Sponsor: AUM Cardiovascular, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02515825
• Collaborator: (none)
• Enrollment: 101
• Locations: 3
• Duration (Months): 1
• Patients Per Site: 33.7
• Patients Per Site Per Month: 33.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 101 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of Participants With CADence-related Adverse Events [24 hours or discharge from hospital, whichever is sooner]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 41 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC	Huntsville	Alabama	United States	35801
2	MedStar Union Memorial Hospital	Baltimore	Maryland	United States	21218
3	St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102

Sponsors and Collaborators

• AUM Cardiovascular, Inc.

Investigators

• Study Chair: Carmelo Panetta, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AUM Cardiovascular, Inc.
• ClinicalTrials.gov Identifier: NCT02515825
• Other Study ID Numbers: 1217-001
• First Posted: Aug 5, 2015
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	Subjects >40 years of age and scheduled for clinically-indicated angiography were recruited at 3 hospitals across the US.

Arm/Group Title	AMBIENCE Study	AMBIENCE Plus R & R
Arm/Group Description	Participants in the initial AMBIENCE study period	Participants in the AMBIENCE plus Repeatability and Reproducibility portion of the study
Period Title: Overall Study
STARTED	70	31
COMPLETED	70	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	AMBIENCE	AMBIENCE Plus R&R Substudy	Total
Arm/Group Description	CADence System testing followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram	CADence System testing for repeatability and reproducibility (4x by 2 operators) followed by coronary angiogram CADence System: Obtain CADence data under normal conditions for comparison of results with those of coronary angiogram. This part of the study includes patients who are a part of the AMBIENCE study.	Total of all reporting groups
Overall Participants	70	31	101
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	46 65.7%	18 58.1%	64 63.4%
>=65 years	24 34.3%	13 41.9%	37 36.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.14 (8.82)	64.65 (11.14)	63.60 (9.56)
Sex: Female, Male (Count of Participants)
Female	23 32.9%	6 19.4%	29 28.7%
Male	47 67.1%	25 80.6%	72 71.3%
Race/Ethnicity, Customized (Count of Participants)
White	55 78.6%	23 74.2%	78 77.2%
Black or African American	12 17.1%	6 19.4%	18 17.8%
Asian	1 1.4%	0 0%	1 1%
Other	2 2.9%	2 6.5%	4 4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The Ambience study included a sub-study within the same population. The sub-study was to evaluate the repeatability and reproducibility of the CADence System. Repeatability refers to the ability of the same System operator to obtain the same results each time the same subject is tested with the same System at two points in time. Reproducibility refers to the ability of different operators to obtain the same results when they evaluate the same subjects with either the same or different Systems.

Arm/Group Title	Patient CADence Result	Repeatability and Reproducibility
Arm/Group Description	CADence System testing followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram	The purpose of the study is to collect performance information regarding the use of the CADence system under normal conditions of use. Includes a 31-subject sub-study to assess the repeatability and reproducibility of the CADence system
Measure Participants	101	31
Count of Participants [Participants]	101 144.3%	31 100%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants were assessed and none had adverse events

Arm/Group Title	Adverse Events
Arm/Group Description	There were zero reported adverse events.
Measure Participants	101
Adverse Events	0 0%
No adverse events	101 144.3%

Adverse Events

Time Frame	Adverse event information was only collected through study exit for each subject (1 day).
Adverse Event Reporting Description	All Adverse Events (AEs) and Serious Adverse Events (SAEs) associated with CADence use through discharge were recorded. Those associated with the coronary angiogram and/or subsequent interventions were not collected.
Arm/Group Title	AMBIENCE		AMBIENCE Plus R&R Substudy
Arm/Group Description	CADence System testing followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram		CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram
All Cause Mortality
	AMBIENCE		AMBIENCE Plus R&R Substudy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/31 (0%)
Serious Adverse Events
	AMBIENCE		AMBIENCE Plus R&R Substudy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	AMBIENCE		AMBIENCE Plus R&R Substudy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.