Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases
CADENCE
1 other identifier
interventional
N/A
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2012
Shorter than P25 for not_applicable coronary-artery-disease
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJuly 1, 2013
June 1, 2013
5 months
April 2, 2012
June 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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%.
within three months
Interventions
Non-invasive detection of \> or equal to 50% stenosis in any of the major coronary arteries.
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Willing and able to give informed consent
- Indicated for angiography evaluation.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Abbott/Minneapolis Heart Institute
Minneapolis, Minnesota, 55455, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Columbia University
New York, New York, 10032, United States
Mt. Sinai
New York, New York, 10032, United States
Cheyenne Vascular & Heart Institute
Cheyenne, Wyoming, 82001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
- PRINCIPAL INVESTIGATOR
Giora Weisz, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2012
First Posted
April 25, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
July 1, 2013
Record last verified: 2013-06