Acute Coronary Syndrome Clinical Trial
— PHECG2Official title:
Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)
NCT number | NCT03699137 |
Other study ID # | ECCCR_PHECG2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 6, 2019 |
Est. completion date | April 1, 2020 |
Verified date | April 2020 |
Source | Kingston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 420048 |
Est. completion date | April 1, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | West Midlands Ambulance Service | Brierley Hill | West Midlands |
United Kingdom | Welsh Ambulance Services NHS Trust | Cardiff | Wales |
United Kingdom | South Western Ambulance Service NHS Foundation Trust | Exeter | Devon |
Lead Sponsor | Collaborator |
---|---|
Kingston University | London Ambulance Service, South West Ambulance Service NHS Foundation Trust, Swansea University, University of Leeds, West Midlands Ambulance Service NHS Foundation Trust |
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WP1: 30-day mortality | Proportion of patients who die within 30 days of the date of their event | 30 days | |
Secondary | Time to death | Length of time in days from ACS event to death | Up to one year | |
Secondary | Hospital mortality | Proportion of patients in each group who die during the (initial) hospital stay following their event | Up to 90 days | |
Secondary | One year mortality | Proportion of patients in each group who die within one year of their ACS event. | One year | |
Secondary | Time under care of EMS | Length of time from EMS arrival on scene to patient arrives at hospital. | Up to 3 hours | |
Secondary | Use and type of reperfusion | Proportion of patients with STEMI who receive reperfusion treatment (pPCI or fibrinolytic). | 24 hours | |
Secondary | Time to treatment | Time in minutes from initial EMS call to patients first recorded reperfusion treatment.(STEMI only) | 24 hours |
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