Coronary Artery DiseaseCADENCENCT01584622
Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases
A study testing CADence System in people with Coronary Artery Disease, run by AUM Cardiovascular, Inc. at 7 sites in United States.
Trial summary
The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CADence System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Willing and able to give informed consent
- Indicated for angiography evaluation.
Who cannot join
- Pregnant or nursing
- Presence of pacemaker/defibrillator
- Presence of artificial valve
- Presence of severe valve disease
- Presence of congenital heart defect
- Left Ventricular Assist Device (LVAD)
Show all 15Show fewer
- Presence of a bypass graft
- Presence of scars on the site thorax areas
- Coarctation of the aorta
- Participation in trial within 30 days prior to collecting CADenceTM data
- Asthma with wheezing
- Inability to lie flat in the supine position
- Acute STEMI
- Heart Transplant
- Recent Cocaine Use
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cheyenne Vascular & Heart Institute
Cheyenne, Wyoming, 82001
Mercy Hospital
Coon Rapids, Minnesota, 55433
Iowa Heart Center
Des Moines, Iowa, 50314
Abbott/Minneapolis Heart Institute
Minneapolis, Minnesota, 55455
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University
New York, New York, 10032
Mt. Sinai
New York, New York, 10032
About this study
Official title: Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases
The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.
- Conditions
- Coronary Artery Disease
- Being tested
- CADence System
- 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.
CADence SystemDevice
Also called AUM Cardiovascular, Inc.
Non-invasive detection of > or equal to 50% stenosis in any of the major coronary arteries.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
The CADence System will be considered to have demonstrated effectiveness in detecting greater than or equal to 50% coronary artery stenosis anywhere in the coronary tree if the estimated sensitivity as compared to angiography is statistically higher than 70%.
Measured: within three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUM Cardiovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Wilson, MD, Study chair, University of MinnesotaRoxana Mehran, MD, Study chair, Mt. SinaiJames Chapman, MD, Principal investigator, Cheyenne Vascular & Heart InstituteMark Tannenbaum, PhD, Principal investigator, Iowa Heart CenterRobert Schwartz, MD, Principal investigator, Abbott/Minneapolis Heart InstituteJeff Chambers, MD, Principal investigator, Mercy HospitalGiora Weisz, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584622
- Sponsor's protocol ID
- AUM1040-001
- Acronym
- CADENCE
- Status last verified
- Jun 2013
- First submitted
- 2 Apr 2012
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases
- ClinicalTrials.gov ID
- NCT01584622
- Acronym / sponsor ID
- CADENCE / AUM1040-001
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AUM Cardiovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Willing and able to give informed consent
- Indicated for angiography evaluation.
Key exclusion criteria (15 listed)
- Pregnant or nursing
- Presence of pacemaker/defibrillator
- Presence of artificial valve
- Presence of severe valve disease
- Presence of congenital heart defect
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 SystemAlso: AUM Cardiovascular, Inc.Non-invasive detection of > or equal to 50% stenosis in any of the major coronary arteries. | Device | – |
Primary outcome
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
Time frame: within three months
The CADence System will be considered to have demonstrated effectiveness in detecting greater than or equal to 50% coronary artery stenosis anywhere in the coronary tree if the estimated sensitivity as compared to angiography is statistically higher than 70%.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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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.
Robert Wilson, MD study chair
University of Minnesota
Roxana Mehran, MD study chair
Mt. Sinai
James Chapman, MD principal investigator
Cheyenne Vascular & Heart Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADence System in people with Coronary Artery Disease, run by AUM Cardiovascular, Inc. at 7 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 15 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: withdrawn, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree. (time frame: within three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2013.