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

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT04488913
Collaborator
Beckman Coulter, Inc. (Industry)
32,609
1
2
19.1
1705.4

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
  • Other: RACE-IT Pathway
  • Other: Standard of Care
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

Study Type:
Interventional
Actual Enrollment :
32609 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Stepped-Wedge Cluster RandomizedStepped-Wedge Cluster Randomized
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
Actual Study Start Date :
Jul 29, 2020
Actual Primary Completion Date :
Apr 3, 2021
Actual Study Completion Date :
Mar 3, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Joseph Miller, MD, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT04488913
Other Study ID Numbers:
  • pending
First Posted:
Jul 28, 2020
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joseph Miller, MD, Principal Investigator, Henry Ford Health System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022