Performance of the Acoustic Based CADScor System in Coronary Artery Disease

INTEGRIS Baptist Medical Center

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Angina (stable)

Treatments: Diagnostic Test: Acoustic Detection of Blood Flow

Study type: Observational

Funder types: Other

Identifiers

NCT06655779

Integrisbmc

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.