MACE CDS Software Master Enrollment Protocol

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Events
• Intervention / Treatment: Device: Index Event

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • Johns Hopkins University
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Kettering Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• All genders, races, ethnicities

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Index Event; Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit	Device: Index Event; Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.
• Investigators: Study Director: Alicia Drain, Beckman Coulter

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Emergency Department; Major Adverse Cardiac Events
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Cardiovascular Diseases
• Other Study ID Numbers: 2.7.2.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes