NCT01584622WithdrawnNot Applicable
Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- AUM Cardiovascular, Inc.
- Locations
- 7
- Primary Endpoint
- Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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%.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Not Applicable
Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery DiseaseAngina PectorisArteriosclerosisCoronary Artery DiseaseMyocardial IschemiaNCT02264717University of Aarhus1,676
Unknown
Not Applicable
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation StudyCardiovascular DiseasesCoronary Artery DiseaseCoronary OcclusionAtherosclerosisNCT04562142AusculSciences Canada Inc.395
Completed
Not Applicable
Clinical Evaluation of the CADence Device in Detection of Coronary Artery DiseasesCoronary Artery DiseaseNCT01743040AUM Cardiovascular, Inc.1,014
Completed
Not Applicable
Computer Aided Detection of Polyps in ColonoscopyColorectal PolypNCT04754347Iterative Scopes, Inc1,472
Not yet recruiting
Not Applicable
Accuracy of Computer-aided (CADx) System in Real-time Characterization of Colorectal Ulcerative DiseasesColorectal UlcersComputer-aided SystemNCT06207825Nanfang Hospital, Southern Medical University495