Coronary Artery DiseaseAMBIENCENCT02515825

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

An observational study of Coronary Artery Disease, run by AUM Cardiovascular, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 41 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: CADence
Type of treatment: Medical device
How many people: 101 participants
Where: 3 sitesUnited States
Study dates: May 2016to Jun 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 41 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Read the 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.

Conditions: Coronary Artery Disease
Being tested: CADence
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CADenceDevice

Study groups in NCT02515825
Study group	Role	What they receive
AMBIENCE		CADence System testing followed by coronary angiogram Receives: Device: CADence
AMBIENCE plus R&R Substudy		CADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram Receives: Device: CADence

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours or discharge from hospital, whichever is sooner

Secondary outcomes (1)

Number of Participants With CADence-related Adverse Events
Measured: 24 hours or discharge from hospital, whichever is sooner

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Jun 2016

First posted5 Aug 2015 (estimated)
Study startMay 2016
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02515825
Sponsor's protocol ID: 1217-001
Acronym: AMBIENCE
Status last verified: Mar 2021
First submitted: 3 Aug 2015
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Data will not be shared

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)
ClinicalTrials.gov ID: NCT02515825
Acronym / sponsor ID: AMBIENCE / 1217-001
Conditions: Coronary Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: AUM Cardiovascular, Inc.Industry (pharma, biotech, devices)
Study start: May 2016
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 5 Aug 2015 (estimated)
Results: Posted 15 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
AMBIENCE	–	Device: CADenceCADence System testing followed by coronary angiogram
AMBIENCE plus R&R Substudy	–	Device: CADenceCADence System testing for repeatibility and reproducibility (4x by 2 operators) followed by coronary angiogram

Who may qualify

Ages: 41 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects already scheduled for coronary angiography who meet study inclusion and exclusion criteria.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CADence	Device	AMBIENCE, AMBIENCE plus R&R Substudy

Primary outcome

Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate
Time frame: 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 15 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMBIENCE Study	70	70
AMBIENCE Plus R & R	31	31

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

Time frame: 24 hours or discharge from hospital, whichever is sooner. Count of participants. Unit: Participants

Measure	Patient CADence Result n = 101	Repeatability and Reproducibility n = 31
Value	101	31

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event information was only collected through study exit for each subject (1 day).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AMBIENCE	0 of 70 (0%)	0 of 70 (0%)	0 of 70
AMBIENCE Plus R&R Substudy	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Data will not be shared

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carmelo Panetta, MD study chair

University of Minnesota

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by AUM Cardiovascular, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate (time frame: 24 hours or discharge from hospital, whichever is sooner). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02515825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.