Clinical trial NCT04488913: Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin
Official title: Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Myocardial Ischemia
Keywords: high-sensitivity troponin
chest pain
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Beckman Coulter, Inc.
First posted: 2020-07-28
Enrollment: 32609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-Wedge Cluster Randomized
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Safe ED discharge
timeFrame: 30 days after initial presentation
Secondary outcomes:
measure: Length of hospital stay
timeFrame: From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.
measure: Number of participants with death or acute myocardial infarction
timeFrame: 30-day and through 1 year
measure: Number of participants with revascularization or rehospitalization for cardiovascular disease
timeFrame: 30-days
measure: Composite number of cardiology resources utilized
timeFrame: 30-days
measure: Hospital payments received
timeFrame: 30-days
Other outcomes:
measure: Pre-specified sub-group analyses of the primary outcome
timeFrame: 30 days
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
citation: Miller J, Cook B, Singh-Kucukarslan G, Tang A, Danagoulian S, Heath G, Khalifa Z, Levy P, Mahler SA, Mills N, McCord J. RACE-IT - Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial. Contemp Clin Trials Commun. 2021 Apr 23;22:100773. doi: 10.1016/j.conctc.2021.100773. eCollection 2021 Jun.