MACE CDS Software Master Enrollment Protocol

Beckman Coulter

Status: Withdrawn

Conditions: Cardiac Events

Treatments: Device: Index Event

Study type: Observational

Funder types: Industry

Identifiers

NCT06257628

2.7.2.1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 23+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All genders, races, ethnicities

Exclusion criteria

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

Trial design

0 participants in 1 patient group

Index Event

Description:

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

Treatment:

Device: Index Event