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NCT Number: NCT06655779

Performance of the Acoustic Based CADScor System in Coronary Artery Disease

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.

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Key information

Conditions

Coronary Artery Disease Angina (Stable) Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acoustic Detection of Blood Flow

Diagnostic Test

Subject will have the acoustic device scoring performed prior to a Coronary CTA. No treatment decisions will be based upon the acoustic device score.

Primary outcomes

  1. Primary Objective

    Time frame: 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Jill Fife, RN

CONTACT

[email protected]

405-951-8607

Linda Pitchford, RN, APRN

CONTACT

[email protected]

405-949-3648

Sponsors and collaborators

Lead sponsor

INTEGRIS Baptist Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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