Pre-hospital ECG in Acute Coronary Syndromes

NCT03699137 | Completed

• 1 other identifier: ECCCR_PHECG2
• Study Type: observational
• Target: 420,048
• Locations: 1 country
• Sites: 3

Brief Summary

The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance clinicians assess patients with suspected acute coronary syndrome (heart attack), and provides clinical data to inform ongoing care. This project builds on previous work by this team, which found that one in three eligible patients did not receive a PHECG, but those that did had a lowered risk of short-term death. In this study the investigators will update that work, and explore reasons for variations in practice - highlighting opportunities to improve care and outcomes. Using routinely collected data and qualitative methods, the investigators will research patient, practitioner and contextual factors contributing to the decision to administer a PHECG. The aim is also to develop an intervention to increase the proportion of eligible patients that receive a PHECG, and to produce a proposal for further funding to test this intervention in a subsequent randomised trial.

Conditions

Acute Coronary Syndrome; STEMI; Non STEMI

Keywords

Acute coronary syndrome; Emergency Medical Services; Electrocardiogram; Outcomes

Outcome Measures

Primary Outcomes (1)

• WP1: 30-day mortality

  Proportion of patients who die within 30 days of the date of their event

  30 days

Secondary Outcomes (6)

• Time to death

  Up to one year

• Hospital mortality

  Up to 90 days

• One year mortality

  One year

• Time under care of EMS

  Up to 3 hours

• Use and type of reperfusion

  24 hours

Study Arms (2)

Cases with confirmed ACS

Cases with confirmed diagnosis of acute coronary syndrome in the MINAP database (national registry of ACS patients). No interventions apply to this group as this is an observational study.

Other: No interventions

EMS personnel

Emergency Medical Service (EMS) personnel will take part in the focus group. No intervention applies to this group in this qualitative component of the study.

Other: No interventions

Interventions

No interventions OTHER

No interventions

Cases with confirmed ACS; EMS personnel

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two types of study populations: 1. \- Patients with confirmed diagnosis of ACS in MINAP database as per inclusion and exclusion criteria 2. \- Emergency Medical Service personnel who have been trained to perform 12 lead ECG.

You may qualify if:

• Patients \> 18 years of age
• Patients with ACS
• Patients who have been brought to hospital by Emergency Medical Service (EMS)
• Patients included in the MINAP registry
• First episode of ACS
• Patients with confirmed STEMI and NSTEMI
• EMS personnel trained in performing an ECG in the pre-hospital setting
• EMS personnel involved in care of patients with a suspected heart attack

You may not qualify if:

• patients \< 18 years of age
• patients who self-presented at hospitals with suspected ACS
• patients who developed ACS whilst in hospital

Sponsors & Collaborators

• Kingston University: lead
• Swansea University: collaborator
• University of Leeds: collaborator
• London Ambulance Service: collaborator
• West Midlands Ambulance Service NHS Foundation Trust: collaborator
• South West Ambulance Service NHS Foundation Trust: collaborator

Study Sites (3)

South Western Ambulance Service NHS Foundation Trust

Exeter, Devon, EX2 7HY, United Kingdom

Location

Welsh Ambulance Services NHS Trust

Cardiff, Wales, CF11 8PL, United Kingdom

Location

West Midlands Ambulance Service

Brierley Hill, West Midlands, DY5 1LX, United Kingdom

Location

Related Publications (31)

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  PMID: 31803487 DERIVED

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MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Tom Quinn, FESC FAHA FACC

  Kingston University & St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 9, 2018
• Study Start: May 6, 2019
• Primary Completion: December 31, 2019
• Study Completion: April 1, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)