Cardiac Events
Conditions
Keywords
Emergency Department, Major Adverse Cardiac Events
Brief 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.
Interventions
DEVICEIndex Event
Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
23 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All genders, races, ethnicities
Exclusion criteria
* ≤ 18 years old presenting to the ED and for clinical validation only, adults \< 22 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity | Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome) | 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). |
Countries
United States
Outcome results
None listed