NCT04488913

Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32,609 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).

Detailed description

This is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new protocol is executed across 9 EDs within an integrated health system, the investigators will study its effects on patient and system-level metrics. A modified stepped wedge design will be utilized that allows comparison of the RACE-IT pathway with standard of care management

Conditions

• Chest Pain
• Myocardial Ischemia

Interventions

Type	Name	Description
OTHER	RACE-IT Pathway	This care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score
OTHER	Standard of Care	Standard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score

Timeline

• Start date: 2020-07-29
• Primary completion: 2021-04-03
• Completion: 2022-03-03
• First posted: 2020-07-28
• Last updated: 2022-03-23

Locations

1 site across 1 country: United States