Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin (RACE-IT)

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

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).

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Chest Pain
• Intervention / Treatment: Other: Standard of Care; Other: RACE-IT Pathway

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 Type: Interventional
• Enrollment (Actual): 32609
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Beckman Coulter, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 29, 2020
• Primary Completion (ACTUAL): April 3, 2021
• Study Completion (ACTUAL): March 3, 2022

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (ACTUAL): July 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chest pain; high-sensitivity troponin
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Myocardial Ischemia; Hypersensitivity; Ischemia; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: Pending (Pending)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No