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

Primary Purpose

Chest Pain, Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RACE-IT Pathway
Standard of Care
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring high-sensitivity troponin, chest pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Standard of Care Treatment

RACE-IT pathway

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of hospital stay
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
Death or presence of acute myocardial infarction determined by adjudication panel
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
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
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.

Full Information

First Posted
July 19, 2020
Last Updated
March 21, 2022
Sponsor
Henry Ford Health System
Collaborators
Beckman Coulter, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04488913
Brief Title
Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin
Acronym
RACE-IT
Official Title
Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
April 3, 2021 (Actual)
Study Completion Date
March 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Beckman Coulter, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Myocardial Ischemia
Keywords
high-sensitivity troponin, chest pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-Wedge Cluster Randomized
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Treatment
Arm Type
Other
Arm Description
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.
Arm Title
RACE-IT pathway
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
RACE-IT Pathway
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Safe ED discharge
Description
Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
Time Frame
30 days after initial presentation
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit
Time Frame
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.
Title
Number of participants with death or acute myocardial infarction
Description
Death or presence of acute myocardial infarction determined by adjudication panel
Time Frame
30-day and through 1 year
Title
Number of participants with revascularization or rehospitalization for cardiovascular disease
Description
revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia
Time Frame
30-days
Title
Composite number of cardiology resources utilized
Description
Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention
Time Frame
30-days
Title
Hospital payments received
Description
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.
Time Frame
30-days
Other Pre-specified Outcome Measures:
Title
Pre-specified sub-group analyses of the primary outcome
Description
We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34013092
Citation
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.
Results Reference
derived

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Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

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