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

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease

• Registration Number: NCT01584622
• Lead Sponsor: AUM Cardiovascular, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-25
• Study Start: 2012-07
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.	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%.

Trial Locations

Locations (7)

Iowa Heart Center; 🇺🇸 Des Moines, Iowa, United States

Mercy Hospital; 🇺🇸 Coon Rapids, Minnesota, United States

Abbott/Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Columbia University; 🇺🇸 New York City, New York, United States

Mt. Sinai; 🇺🇸 New York City, New York, United States

Cheyenne Vascular & Heart Institute; 🇺🇸 Cheyenne, Wyoming, United States