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| Name | Class |
|---|---|
| Beckman Coulter, Inc. | INDUSTRY |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Treatment | Other | 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 | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RACE-IT Pathway | Other | 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-specified sub-group analyses of the primary outcome | We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40279128 | Derived | Miller J, Cook B, Gunaga S, Fadel R, Gandolfo C, Emakhu J, Mills NL, Mahler S, Levy P, Parikh S, Krupp S, Hawatian K, Nour K, Klausner H, Gindi R, Hudson M, Perrotta G, Zweig B, Lanfear D, Kim H, Danagoulian S, Keerie C, Nassereddine H, Morton T, Affas Z, Husain A, McCord J; RACE-IT Research Group. Health Care Resource Utilization for Patients With Suspected Myocardial Infarction: A Secondary Analysis of the RACE-IT Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e256930. doi: 10.1001/jamanetworkopen.2025.6930. | |
| 40272800 |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Stepped-Wedge Cluster Randomized
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| Standard of Care | Other | 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 |
|
| 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 |
| Derived |
| Glintborg D, Moller JK, Rubin KH, Lidegaard O, T'Sjoen G, Larsen MJO, Hilden M, Lehmann Christensen L, Andersen MS. Mental and Physical Health Among Danish Transgender Persons Compared With Cisgender Persons. JAMA Netw Open. 2025 Apr 1;8(4):e257115. doi: 10.1001/jamanetworkopen.2025.7115. |
| 34013092 | Derived | 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. |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |