CADence Performance as a Rule-Out Modality in Long Beach Veterans Administration Heart Catheterization Lab Patients

Coronary Artery Disease Clinical Trial

— SOLDIER  

Official title:

CADence Performance as a Rule-Out Modality in Long Beach Veterans Administration Heart Catheterization Lab Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03116438
• Other study ID #: 1358-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2017
• Last updated: April 14, 2017
• Start date: June 16, 2017
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: VA Long Beach Healthcare System
• Contact: Jacqueline A Nguyen, BA
• Phone: 562-826-8000
• Email: jacqueline.nguyen[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and performance of the CADence device by comparing it to the results obtained from standard coronary angiography. The CADence device collects acoustic (sound) data from locations on the chest for the purpose of identifying coronary artery turbulence, which may be indicative of coronary artery disease.

Description:

The purpose of the study is to evaluate the safety and performance of the CADence device by comparing it to the results obtained from standard coronary angiography. The CADence device collects acoustic (sound) data from locations on the chest for the purpose of identifying coronary artery turbulence, which may be indicative of coronary artery disease (CAD). The CADence3 is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds. Turbulence within the coronary arteries produces a distinct audio signal that can be identified using a proprietary algorithm built into the device. The CADence System is indicated for patients that have chest pains in addition to at least two other coronary artery disease risk factors such as obesity and hypertension. The device intends to be an alternative screening tool to nuclear stress testing for detecting coronary artery blockages. CADence acquires and records the acoustic signals of the heart and analyzes these signals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age >40 years

• Clinical indication for non-emergency coronary angiogram

• Willing and able to give informed consent

• Negative pregnancy test for women of childbearing potential (within last 7 days)

Exclusion Criteria:

• Pregnancy or lactation

• Subjects with emergent cardiac conditions

• Body Mass Index (BMI) <18.5 or >40

• Prior bypass surgery or coronary stenting

• Presence of pacemaker/defibrillator

• Presence of artificial valve

• Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta

• Presence of murmurs, including valve lesions, ventricular septal defects and AV fistulae

• Presence of moderate-severe valve disease

• Left Ventricular Assist Device (LVAD)

• Presence of scars on the site thorax areas

• Participation in trial within 30 days prior to collecting CADence data except participation in study studies.

• Asthma or COPD with active wheezing

• Inability to lie in supine position

• Heart Transplant

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Vascular Diseases

Intervention

Device:
• CADence
The CADence device collects acoustic (sound) data from locations on the chest for the purpose of identifying coronary artery turbulence, which may be indicative of coronary artery disease. The test will take approximately 15 minutes to complete. There are no follow-up procedures associated with the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Long Beach Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Agreement	Percent positive agreement and percent negative agreement of CADence device under normal use conditions as compared to coronary angiogram.	six months