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Pre-hospital ECG in Acute Coronary Syndromes (PHECG2)

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ClinicalTrials.gov Identifier: NCT03699137
Recruitment Status : Not yet recruiting
First Posted : October 8, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Swansea University
University of Leeds
London Ambulance Service
West Midlands Ambulance Service NHS Foundation Trust
South West Ambulance Service NHS Foundation Trust
Information provided by (Responsible Party):
Kingston University

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.


Condition or disease Intervention/treatment
Acute Coronary Syndrome STEMI Non STEMI Other: No interventions

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 420048 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
No interventions




Primary Outcome Measures :
  1. WP1: 30-day mortality [ Time Frame: 30 days ]
    Proportion of patients who die within 30 days of the date of their event


Secondary Outcome Measures :
  1. Time to death [ Time Frame: Up to one year ]
    Length of time in days from ACS event to death

  2. Hospital mortality [ Time Frame: Up to 90 days ]
    Proportion of patients in each group who die during the (initial) hospital stay following their event

  3. One year mortality [ Time Frame: One year ]
    Proportion of patients in each group who die within one year of their ACS event.

  4. Time under care of EMS [ Time Frame: Up to 3 hours ]
    Length of time from EMS arrival on scene to patient arrives at hospital.

  5. Use and type of reperfusion [ Time Frame: 24 hours ]
    Proportion of patients with STEMI who receive reperfusion treatment (pPCI or fibrinolytic).

  6. Time to treatment [ Time Frame: 24 hours ]
    Time in minutes from initial EMS call to patients first recorded reperfusion treatment.(STEMI only)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699137


Contacts
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Contact: Lucia Gavalova, BSc +447878662026 phecg2study@sgul.kingston.ac.uk

Locations
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United Kingdom
South Western Ambulance Service NHS Foundation Trust Not yet recruiting
Exeter, Devon, United Kingdom, EX2 7HY
Contact: Sarah Black, PhD    00441392261640    sarah.black@swast.nhs.uk   
Contact: Maria Robinson    00441392 261655    maria.robinson@swast.nhs.uk   
Welsh Ambulance Services NHS Trust Not yet recruiting
Cardiff, Wales, United Kingdom, CF11 8PL
Contact: Nigel Rees, MSc    00442920932903    nigel.rees5@wales.nhs.uk   
West Midlands Ambulance Service Not yet recruiting
Brierley Hill, West Midlands, United Kingdom, DY5 1LX
Contact: Andy Rosser, MCPara    00447825451538    andy.rosser@wmas.nhs.uk   
Sponsors and Collaborators
Kingston University
Swansea University
University of Leeds
London Ambulance Service
West Midlands Ambulance Service NHS Foundation Trust
South West Ambulance Service NHS Foundation Trust
Investigators
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Principal Investigator: Tom Quinn, FESC FAHA FACC Kingston University & St George's, University of London

Additional Information:
Publications:
National Institute for Health and Care Excellence. Myocardial infarction with ST-segment elevation: acute management. Clinical guideline [CG167] July 2013
19. MRC. Developing and evaluating complex interventions: new guidance. 2006. Accessed at https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/ June 2017.
Creswell J and Plano Clark V. Designing and conducting mixed methods research. Second Edition 2006; Sage.
National Institute for Cardiovascular Outcomes Research. Myocardial Ischaemia National Audit Project. Heart attack in England, Wales and Northern Ireland. Annual Public Report April 2015 - March 2016. June 2017.
Ritchie J, Lewis J, Nicholls CMN, et al. Qualitative research practice: A guide for social science students and researchers. Sage 2013.
National Institute for Health and Clinical Excellence. Behaviour Change at Population, Community and Individual Levels. NICE Public Health Guidance. London: NICE, 2007
Kvale, S. InterViews: An introduction to qualitative research interviewing. Thousand Oaks, CA: Sage 1996.

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Responsible Party: Kingston University
ClinicalTrials.gov Identifier: NCT03699137     History of Changes
Other Study ID Numbers: ECCCR_PHECG2
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kingston University:
Acute coronary syndrome
Emergency Medical Services
Electrocardiogram
Outcomes

Additional relevant MeSH terms:
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Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases