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Trial record 4 of 18 for:    cardiac catheterization | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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

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ClinicalTrials.gov Identifier: NCT03116438
Recruitment Status : Not yet recruiting
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Arnold Seto, VA Long Beach Healthcare System

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Device: CADence Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CADence Performance as a Rule-Out Modality in Long Beach Veterans Administration Heart Catheterization Lab Patients
Estimated Study Start Date : June 16, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: CADence3 Device
If you agree to participate in this study, you will be asked to allow recording of sounds from four (4) sites on your chest using the CADence device. The CADence test will take approximately 15 minutes to complete. This is a single-arm study.
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.
Other Name: CADence3




Primary Outcome Measures :
  1. Percent Agreement [ Time Frame: six months ]
    Percent positive agreement and percent negative agreement of CADence device under normal use conditions as compared to coronary angiogram.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116438


Contacts
Contact: Jacqueline A Nguyen, BA 562-826-8000 ext 2973 jacqueline.nguyen@va.gov
Contact: Daniel Amador 562-826-8000 ext 2973 daniel.amador@va.gov

Sponsors and Collaborators
VA Long Beach Healthcare System
Investigators
Principal Investigator: Arnold H Seto, MD,MPA LBVAHS

Responsible Party: Arnold Seto, Chief of Cardiology, VA Long Beach Healthcare System
ClinicalTrials.gov Identifier: NCT03116438     History of Changes
Other Study ID Numbers: 1358-001
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arnold Seto, VA Long Beach Healthcare System:
Coronary Artery Disease
Nuclear Stress Test
CT Angiography
Angiography

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes