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Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases (CADENCE)

Primary Purpose

Coronary Artery Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CADence System
Sponsored by
AUM Cardiovascular, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iowa Heart Center
  • Mercy Hospital
  • Abbott/Minneapolis Heart Institute
  • University of Minnesota
  • Columbia University
  • Mt. Sinai
  • Cheyenne Vascular & Heart Institute

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2012
Last Updated
June 27, 2013
Sponsor
AUM Cardiovascular, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01584622
Brief Title
Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases
Acronym
CADENCE
Official Title
Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AUM Cardiovascular, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CADence System
Other Intervention Name(s)
AUM Cardiovascular, Inc.
Intervention Description
Non-invasive detection of > or equal to 50% stenosis in any of the major coronary arteries.
Primary Outcome Measure Information:
Title
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
Description
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%.
Time Frame
within three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wilson, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roxana Mehran, MD
Organizational Affiliation
Mt. Sinai
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James Chapman, MD
Organizational Affiliation
Cheyenne Vascular & Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Tannenbaum, PhD
Organizational Affiliation
Iowa Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Schwartz, MD
Organizational Affiliation
Abbott/Minneapolis Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeff Chambers, MD
Organizational Affiliation
Mercy Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giora Weisz, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Abbott/Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Columbia University
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mt. Sinai
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cheyenne Vascular & Heart Institute
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases

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