MedTrace Logo

MACE CDS Software Master Enrollment Protocol

NCT06257628 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-11-12

No results posted yet for this study

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.

Conditions

  • Cardiac Events

Interventions

DEVICE

Index Event

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

Sponsors & Collaborators

  • Beckman Coulter, Inc.

    lead INDUSTRY

Principal Investigators

  • Alicia Drain · Beckman Coulter

Eligibility

Min Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257628 on ClinicalTrials.gov