Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

Myocardial Ischemia Clinical Trial

— RACE-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488913
• Other study ID #: pending
• Status: Completed
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: March 3, 2022

Study information

• Verified date: March 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32609
• Est. completion date: March 3, 2022
• Est. primary completion date: April 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Hypersensitivity
• Ischemia
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-specified sub-group analyses of the primary outcome	We will explore analysis assessing gender-specific cut-points for hs-cTnI associated with safe discharge	30 days
Primary	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	30 days after initial presentation
Secondary	Length of hospital stay	Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit	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.
Secondary	Number of participants with death or acute myocardial infarction	Death or presence of acute myocardial infarction determined by adjudication panel	30-day and through 1 year
Secondary	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	30-days
Secondary	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	30-days
Secondary	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.	30-days