MACE CDS Software Master Enrollment Protocol

Cardiac Events Clinical Trial

Official title:

MACE CDS Software Master Enrollment Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257628
• Other study ID #: 2.7.2.1
• Status: Recruiting
• Start date: September 14, 2023
• Est. completion date: April 11, 2025

Study information

• Verified date: February 2024
• Source: Beckman Coulter, Inc.
• Contact: Alicia Drain
• Phone: 512-906-8763
• Email: adrain[@]beckman.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5515
• Est. completion date: April 11, 2025
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years and older

Eligibility

Inclusion Criteria:

• All genders, races, ethnicities

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiac Events
• Cardiovascular Diseases

Intervention

Device:
• Index Event
Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Henry Ford Health System	Detroit	Michigan
United States	Kettering Health	Kettering	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)