NCT06257628

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

October 18, 2023

Last Update Submit

November 10, 2025

Conditions

Cardiac Events

Keywords

Emergency DepartmentMajor Adverse Cardiac Events

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Index Event

Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit

Device: Index Event

Interventions

Index EventDEVICE

Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit

Index Event

Eligibility Criteria

Age23 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All genders, races, ethnicities

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21211, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Kettering Health

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alicia Drain

    Beckman Coulter

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

February 14, 2024

Study Start

September 14, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

November 12, 2025

Record last verified: 2025-11

Locations

US(3)