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OpenTrials
Completed

NCT Number: NCT03494556

Prehospital Translation of Chest Pain Tools

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Lung Diseases Myocardial Ischemia Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS, Fayetteville, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Paramedic will use data collected during routine care to complete four risk stratification tools.

Primary outcomes

  1. 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

  1. Compare decision aids to determine which are the most sensitive and specific

    Time frame: 30 days

    Destination hospitals have well established linkages between the prehospital and hospital Electronic Medical Record (EMR) facilitating patient outcome ascertainment. Data will be abstracted from the EMR to determine occurrence of 30 day study outcomes.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Cape Fear Valley Mobile Integrated Healthcare Cumberland County EMS
  • New Hanover Regional Medical Center

Registry information

Official study title

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

Acronym: RESCUE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 11, 2018
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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