Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

Henry Ford Health System32,609 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

32,609

Conditions

Chest Pain Myocardial Ischemia

Interventions

RACE-IT PathwayOTHER

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 CareOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Henry Ford Health System

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days after initial presentation

Secondary Outcomes

Length of hospital stay

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.

Number of participants with death or acute myocardial infarction

Death or presence of acute myocardial infarction determined by adjudication panel

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 30-days

Data from ClinicalTrials.gov

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