An observational study in Cardiac Events, sponsored by Beckman Coulter, Inc.. Withdrawn at 3 sites in United States. Open to participants aged 23 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by Beckman Coulter, Inc. (part of Danaher Corporation) · Observational
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
Browse Cardiovascular Diseases studies →Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
First submitted after Beckman Coulter, Inc. became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
Patients visiting ED with suspicion of Acute Coronary Syndrome (ACS).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit
Device: Index Event
Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit
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).
Time frame: Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)
Ran from Sep 2023 to primary completion in May 2025, 20 months.
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This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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