Not yet recruiting NCT06655779
Performance of the Acoustic Based CADScor System in Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acoustic Detection of Blood Flow.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Angina (stable). Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Acoustic 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.
Primary outcome measures
- Primary Objective [Time frame: From enrollment through 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- INTEGRIS Baptist Medical Center — Oklahoma City
Identifiers
NCT: NCT06655779 · Integrisbmc