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Completed

NCT Number: NCT04488913

Rapid Acute Coronary Syndrome Exclusion Using 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).

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Key information

Conditions

Chest Pain Cardiovascular Diseases Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Safe ED discharge

    Time frame: 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 outcomes

  1. Length of hospital stay

    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.

    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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Pre-specified sub-group analyses of the primary outcome

    Time frame: 30 days

    We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Beckman Coulter, Inc.

Registry information

Official study title

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

Acronym: RACE-IT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 28, 2020
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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