Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

  • STATUS
    Recruiting
  • End date
    Feb 15, 2022
  • participants needed
    11700
  • sponsor
    Henry Ford Health System
Updated on 17 February 2021
electrocardiogram
troponin
cardiac troponin
acute coronary syndrome
troponin i

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

Details
Condition Chest Pain, Coronary Artery Disease, Coronary heart disease, Vascular Diseases, Heart disease, Pain, Ischemic Heart Disease, Post-Surgical Pain, Pain (Pediatric), Cardiac Ischemia, Myocardial Ischemia, Cardiac Disease, pain chest
Treatment Standard of Care, RACE-IT Pathway
Clinical Study IdentifierNCT04488913
SponsorHenry Ford Health System
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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