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

Coronary Artery Disease Clinical Trial

— CADENCE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01584622
• Other study ID #: AUM1040-001
• Status: Withdrawn
• Phase: N/A
• First received: April 2, 2012
• Last updated: June 27, 2013
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: AUM Cardiovascular, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CADence System
Non-invasive detection of > or equal to 50% stenosis in any of the major coronary arteries.

Locations

Country	Name	City	State
United States	Cheyenne Vascular & Heart Institute	Cheyenne	Wyoming
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Iowa Heart Center	Des Moines	Iowa
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

Sponsors (1)

Lead Sponsor	Collaborator
AUM Cardiovascular, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No