Angina (stable), Coronary Artery Disease
Conditions
Keywords
CADScore
Brief summary
The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.
Interventions
DIAGNOSTIC_TESTAcoustic Detection of Blood Flow
Subject will have the acoustic device scoring performed prior to a Coronary CTA. No treatment decisions will be based upon the acoustic device score.
Sponsors
INTEGRIS Baptist Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * Signed ICF * Male or female, aged 30 years or above * Symptoms suggestive of stable coronary artery disease * No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft). Exclusion: * Asymptomatic for angina or chest pain * Implanted donor heart * Previous Coronary Artery Bypass Graft(CABG) * Previous Coronary Stenting or known CAD * Arrhythmia causing non-sinus rhythm * Fragile or compromised skin, or abnormal anatomy or significant operation scars in the fourth left int3er Costal 9IC4-L) recording area * Implanted mechanical heart or mechanical heart pump * Implanted pacemaker or Cardioverter Defibrillator(ICD), other implanted active electronics or act5ive electronic support equipment closer than 50 cm to the CADScore System.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | From enrollment through 1 year | To determine that the sensitivity of the CAD score in low to intermediate-risk patients referred for coronary CTA in non-inferior to the device specified sensitivity at 89%. |
Countries
United States
Contacts
Primary ContactJill Fife, RN
Backup ContactLinda Pitchford, RN, APRN
Outcome results
None listed