- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584622
Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases (CADENCE)
June 27, 2013 updated by: AUM Cardiovascular, Inc.
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Des Moines, Iowa, United States, 50314
- Iowa Heart Center
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Minnesota
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Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Minneapolis, Minnesota, United States, 55455
- Abbott/Minneapolis Heart Institute
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New York
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New York City, New York, United States, 10032
- Columbia University
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New York City, New York, United States, 10032
- Mt. Sinai
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Wyoming
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Cheyenne, Wyoming, United States, 82001
- Cheyenne Vascular & Heart Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years old
- Willing and able to give informed consent
- Indicated for angiography evaluation.
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
Time Frame: within three months
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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%.
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within three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giora Weisz, MD, Columbia University
- Study Chair: Robert Wilson, MD, University of Minnesota
- Study Chair: Roxana Mehran, MD, Mt. Sinai
- Principal Investigator: James Chapman, MD, Cheyenne Vascular & Heart Institute
- Principal Investigator: Mark Tannenbaum, PhD, Iowa Heart Center
- Principal Investigator: Robert Schwartz, MD, Abbott/Minneapolis Heart Institute
- Principal Investigator: Jeff Chambers, MD, Mercy Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
February 1, 2013
Study Registration Dates
First Submitted
April 2, 2012
First Submitted That Met QC Criteria
April 23, 2012
First Posted (Estimate)
April 25, 2012
Study Record Updates
Last Update Posted (Estimate)
July 1, 2013
Last Update Submitted That Met QC Criteria
June 27, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUM1040-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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