NCT06257628

MACE CDS Software Master Enrollment Protocol

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 23 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Events

Interventions

Type	Name	Description
DEVICE	Index Event	Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-02-14
• Last updated: 2025-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study