Performance of the Acoustic Based CADScor System in Coronary Artery Disease

NCT06655779 | Not Yet Recruiting FDA Device

• 1 other identifier: Integrisbmc
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Angina (stable)

Keywords

CADScore

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  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%.

  From enrollment through 1 year

Interventions

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects to be recruited from INTEGRIS Baptist Medical Center.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• INTEGRIS Baptist Medical Center: lead

Study Sites (1)

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable

Condition Hierarchy (Ancestors)

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

Study Officials

• Jon P Blaschke, MD

  INTEGRIS Baptist Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Fife, RN

CONTACT

405-951-8607; bethany.fife@integrishealth.org

Linda Pitchford, RN, APRN

CONTACT

405-949-3648; linda.pitchford@integrishealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Medical Director of Cardiology Quality, Informatics and Diagnostic Services.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

US (1)