Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Chest Pain, Myocardial Ischemia

Intervention / Treatment
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* Other: RACE-IT Pathway
* Other: Standard of Care


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped-Wedge Cluster Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care Treatment<br>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. | Other: Standard of Care<br>* 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<br>|
| Active Comparator: RACE-IT pathway<br>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) | Other: RACE-IT Pathway<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe ED discharge | Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days | 30 days after initial presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit | 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. | 
| Number of participants with death or acute myocardial infarction | Death or presence of acute myocardial infarction determined by adjudication panel | 30-day and through 1 year | 
| Number of participants with revascularization or rehospitalization for cardiovascular disease | revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia | 30-days | 
| Composite number of cardiology resources utilized | Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention | 30-days | 
| Hospital payments received | The total hospital payments received for the initial ED visit and any subsequent hospitalizations and procedures that are cardiology related over 30-days from the initial encounter. | 30-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-sensitivity troponin, chest pain