Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin (RACE-IT)

Henry Ford Health

Status: Completed

Conditions: Myocardial Ischemia; Chest Pain

Treatments: Other: Standard of Care; Other: RACE-IT Pathway

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04488913

pending (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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

Enrollment: 32,609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.

Exclusion criteria

1. ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
2. Any ED-drawn hs-cTnI value > 99th percentile (18 ng/L)
3. Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
4. A transfer from another facility
5. Primary residence outside the state of Michigan
6. Previous inclusion in the study
7. Enrolled in hospice

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

32,609 participants in 2 patient groups

Standard of Care Treatment

Other group

Description:

Exposure to traditional evaluation for suspected acute coronary syndrome (ACS) with ECG, 0- and 3-hour troponin testing using the 99th percentile as the upper reference limit, and application of the History, EKG, Age, Risk factors, and troponin (HEART) score.

Treatment:

Other: Standard of Care

RACE-IT pathway

Active Comparator group

Description:

Exposure to new protocol for suspected ACS, which includes the use of 0- and 1-hour ECG and high-sensitivity troponin testing and application of the HEAR score (a modification of the HEART score)

Treatment:

Other: RACE-IT Pathway