Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

NCT04488913 | Completed

• 1 other identifier: pending
• Study Type: interventional
• Target: 32,609
• Locations: 1 country
• Sites: 1

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).

Conditions

Chest Pain; Myocardial Ischemia

Keywords

high-sensitivity troponin; chest pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• Number of participants with death or acute myocardial infarction

  30-day and through 1 year

• Number of participants with revascularization or rehospitalization for cardiovascular disease

  30-days

• Composite number of cardiology resources utilized

  30-days

• Hospital payments received

  30-days

Other Outcomes (1)

• Pre-specified sub-group analyses of the primary outcome

  30 days

Study Arms (2)

Standard of Care Treatment

OTHER

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

RACE-IT pathway

ACTIVE COMPARATOR

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

Interventions

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

RACE-IT pathway

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

Standard of Care Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.

You may not qualify if:

• 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
• Enrolled in hospice

Sponsors & Collaborators

• Henry Ford Health System: lead
• Beckman Coulter, Inc.: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

• Miller J, Cook B, Gunaga S, Fadel R, Gandolfo C, Emakhu J, Mills NL, Mahler S, Levy P, Parikh S, Krupp S, Hawatian K, Nour K, Klausner H, Gindi R, Hudson M, Perrotta G, Zweig B, Lanfear D, Kim H, Danagoulian S, Keerie C, Nassereddine H, Morton T, Affas Z, Husain A, McCord J; RACE-IT Research Group. Health Care Resource Utilization for Patients With Suspected Myocardial Infarction: A Secondary Analysis of the RACE-IT Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e256930. doi: 10.1001/jamanetworkopen.2025.6930.

  PMID: 40279128 DERIVED

• Glintborg D, Moller JK, Rubin KH, Lidegaard O, T'Sjoen G, Larsen MJO, Hilden M, Lehmann Christensen L, Andersen MS. Mental and Physical Health Among Danish Transgender Persons Compared With Cisgender Persons. JAMA Netw Open. 2025 Apr 1;8(4):e257115. doi: 10.1001/jamanetworkopen.2025.7115.

  PMID: 40272800 DERIVED

• Miller J, Cook B, Singh-Kucukarslan G, Tang A, Danagoulian S, Heath G, Khalifa Z, Levy P, Mahler SA, Mills N, McCord J. RACE-IT - Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial. Contemp Clin Trials Commun. 2021 Apr 23;22:100773. doi: 10.1016/j.conctc.2021.100773. eCollection 2021 Jun.

  PMID: 34013092 DERIVED

MeSH Terms

Conditions

Chest Pain; Myocardial Ischemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped-Wedge Cluster Randomized

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 28, 2020
• Study Start: July 29, 2020
• Primary Completion: April 3, 2021
• Study Completion: March 3, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

US (1)