RECRUITING

MACE CDS Software Master Enrollment Protocol

Description

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

Study Overview

Study Details

Study overview

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.

MACE CDS Software Master Enrollment Protocol

MACE CDS Software Master Enrollment Protocol

Condition
Cardiac Events
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21211

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Kettering

Kettering Health, Kettering, Ohio, United States, 45429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All genders, races, ethnicities
  • * ≤ 18 years old presenting to the ED and for clinical validation only, adults \< 22 years old

Ages Eligible for Study

23 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beckman Coulter, Inc.,

Alicia Drain, STUDY_DIRECTOR, Beckman Coulter

Study Record Dates

2025-04-11