Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin
- Conditions
- Chest PainMyocardial Ischemia
- Interventions
- Other: Standard of CareOther: RACE-IT Pathway
- Registration Number
- NCT04488913
- Lead Sponsor
- Henry Ford Health System
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32609
- Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard of Care Treatment Standard of Care 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. RACE-IT pathway 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)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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.
Trial Locations
- Locations (1)
Henry Ford Health System
🇺🇸Detroit, Michigan, United States