Performance of the Acoustic Based CADScor System in Coron... | NCT06655779

Studies
Performance of the Acoustic Based CADScor System in Coronary Artery Disease

NCT06655779

Sponsor

INTEGRIS Baptist Medical Center

Status

Not yet recruiting

Last Update Posted

Oct 23, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Angina (stable)

Interventions

Acoustic Detection of Blood Flow

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2024Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

INTEGRIS Cardiovascular Research, M.D., Medical Director of Cardiology Quality, Informatics and Diagnostic Services., INTEGRIS Baptist Medical CenterPrincipal Investigator

Lead Sponsor

INTEGRIS Baptist Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects to be recruited from INTEGRIS Baptist Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jill Fife, RN	Contact	405-951-8607		bethany.fife@integrishealth.org
Linda Pitchford, RN, APRN	Contact	405-949-3648		linda.pitchford@integrishealth.org

Overall Officials

Name	Affiliation	Role
Jon P Blaschke, MD	INTEGRIS Baptist Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INTEGRIS Baptist Medical Center		Oklahoma City	Oklahoma	73112	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D060050	Angina, Stable

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided