RACE-IT: Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Standard of Care Treatment 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
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
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Active Comparator: RACE-IT pathway 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
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
|
Outcome Measures
Primary Outcome Measures
- Safe ED discharge [30 days after initial presentation]
Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
Secondary Outcome Measures
- Length of hospital stay [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.]
Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit
- Number of participants with death or acute myocardial infarction [30-day and through 1 year]
Death or presence of acute myocardial infarction determined by adjudication panel
- Number of participants with revascularization or rehospitalization for cardiovascular disease [30-days]
revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia
- Composite number of cardiology resources utilized [30-days]
Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention
- Hospital payments received [30-days]
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.
Other Outcome Measures
- Pre-specified sub-group analyses of the primary outcome [30 days]
We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge
Eligibility Criteria
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:
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ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
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Any ED-drawn hs-cTnI value > 99th percentile (18 ng/L)
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Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
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A transfer from another facility
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Primary residence outside the state of Michigan
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Previous inclusion in the study
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Enrolled in hospice
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
Sponsors and Collaborators
- Henry Ford Health System
- Beckman Coulter, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- pending