MACE CDS Software Master Enrollment Protocol | NCT06257628

Studies
MACE CDS Software Master Enrollment Protocol

NCT06257628

Sponsor

Beckman Coulter, Inc.

Status

Withdrawn

Last Update Posted

Nov 12, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cardiac Events

Interventions

Index Event

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision

Expanded Access Info

Start Date

Sep 14, 2023Actual

Primary Completion Date

May 31, 2025Actual

Completion Date

May 31, 2025Actual

First Submitted Date

Oct 18, 2023

First Submission Date that Met QC Criteria

Feb 5, 2024

First Posted Date

Feb 14, 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

Nov 10, 2025

Last Update Posted Date

Nov 12, 2025Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events (MACE) Clinical Decision Support (CDS) software.

The data will also be utilized in subsequent clinical validation to support an FDA application and/or applications to other regulatory agencies as needed.

Detailed Description

The primary objective is to develop a machine learning tool which predicts risk of 30-day MACE (major adverse cardiac event) risk stratification among patients visiting ED with suspicion of ACS (Acute Coronary Syndrome).

The data will also be utilized in subsequent clinical validation. In addition to retrospective Electronic Health Record (EHR) data, Health Information Exchange (HIE) data and patient reported outcomes will be collected to capture 30-day MACE outcomes, as applicable.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Index Event		Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit	Device: Index Event

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Index Event	Device	Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit	Index Event

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity	Clinical performance of MACE (Major Adverse Cardiac Events) CDS (Clinical Decision Support) tool to identify a patient's risk of for having a MACE (Major Adverse Cardiac Events) within 30 days, with both a single High-Sensitive Troponin and a second High-Sensitive Troponin (if applicable).	Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All genders, races, ethnicities

Exclusion Criteria:

≤ 18 years old presenting to the ED and for clinical validation only, adults < 22 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients visiting ED with suspicion of Acute Coronary Syndrome (ACS).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alicia Drain	Beckman Coulter	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21211	United States
Henry Ford Health System

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided