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Clinical Trials/NCT03494556
NCT03494556
Completed
Not Applicable

Translating Evidence-Based Chest Pain Decision Aids to the Prehospital Environment

Wake Forest University Health Sciences2 sites in 1 country365 target enrollmentApril 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Wake Forest University Health Sciences
Enrollment
365
Locations
2
Primary Endpoint
Determine whether prehospital chest pain decision aid use is feasible.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary Embolism (PE) and have become standard practice in the ED setting. This study seeks to determine whether prehospital use of these decision aids is feasible and determine which are the most sensitive and specific for prediction of ACS and PE, respectively.

Detailed Description

To accomplish our Specific Aims the study team proposes a prospective, observational pilot study of four rapid risk stratification tools, the HEART Pathway Score, EDACS score, revised Geneva score, and PERC score, among 250 chest pain patients within two large EMS systems. The proposed pilot study has broad-based support from local and state EMS agencies, including Cumberland and New Hanover County EMS agencies. Each tool will be pilot tested and compared in the prehospital setting for feasibility and accuracy. Paramedics will be trained in risk stratification tool use and then will prospectively collect the clinical data needed to calculate each risk stratification score when caring for adults with chest pain. Completed paramedic risk assessments will be used to determine feasibility. Patients will be followed for 30 days to determine occurrence of ACS and PE events and the sensitivity of each risk stratification decision aid will be determined.

Registry
clinicaltrials.gov
Start Date
April 18, 2018
End Date
September 9, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age greater than or equal to 21
  • Acute non-traumatic chest pain
  • Transported by Cumberland or New Hanover County EMS to a local Emergency Department

Exclusion Criteria

  • Patients with evidence of ST elevation myocardial infarction (STEMI) on ECG
  • Inter-facility transports (transfers)
  • Patients with unstable vital signs
  • Prisoners
  • Non-english speakers

Outcomes

Primary Outcomes

Determine whether prehospital chest pain decision aid use is feasible.

Time Frame: 24 hours

Paramedics and blinded Emergency Department providers will be complete four risk stratification tools on a convenience sample of patients with acute chest pain. Inter-rater reliability (kappa) will be determined for each tool.

Secondary Outcomes

  • Compare decision aids to determine which are the most sensitive and specific(30 days)

Study Sites (2)

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