Performance of the Acoustic Based CADScor System in Coronary Artery Disease

NCT ID: NCT06655779

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Angina (stable)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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INTEGRIS Baptist Medical Center

OTHER

Sponsor Role lead

Responsible Party

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INTEGRIS Cardiovascular Research

M.D., Medical Director of Cardiology Quality, Informatics and Diagnostic Services.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon P Blaschke, MD

Role: PRINCIPAL_INVESTIGATOR

INTEGRIS Baptist Medical Center

Locations

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INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Central Contacts

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Jill Fife, RN

Role: CONTACT

405-951-8607

Linda Pitchford, RN, APRN

Role: CONTACT

405-949-3648

Facility Contacts

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Jill Fife, RN

Role: primary

405-951-8607

Linda Pitchford, RN, APRN

Role: backup

405-949-3648

Jon p Blaschke, MD

Role: backup

Other Identifiers

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Integrisbmc

Identifier Type: -

Identifier Source: org_study_id

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