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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Interventions

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CADence System

Non-invasive detection of \> or equal to 50% stenosis in any of the major coronary arteries.

Intervention Type DEVICE

Other Intervention Names

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AUM Cardiovascular, Inc.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No