Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2022-03-03

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Chest Pain Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped-Wedge Cluster Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

Standard of Care

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

RACE-IT Pathway

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No