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

Status

Withdrawn

Conditions

Intervention / Treatment

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

  • United States
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Abbott/Minneapolis Heart Institute
    • New York
      • New York City, New York, United States, 10032
        • Columbia University
      • New York City, New York, United States, 10032
        • Mt. Sinai
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Vascular & Heart Institute

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AUM Cardiovascular, Inc.

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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