Pre-hospital ECG in Acute Coronary Syndromes (PHECG2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03699137|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2018
Last Update Posted : March 6, 2019
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
|Study Type :||Observational|
|Estimated Enrollment :||420048 participants|
|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|
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
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
- WP1: 30-day mortality [ Time Frame: 30 days ]Proportion of patients who die within 30 days of the date of their event
- Time to death [ Time Frame: Up to one year ]Length of time in days from ACS event to death
- Hospital mortality [ Time Frame: Up to 90 days ]Proportion of patients in each group who die during the (initial) hospital stay following their event
- One year mortality [ Time Frame: One year ]Proportion of patients in each group who die within one year of their ACS event.
- Time under care of EMS [ Time Frame: Up to 3 hours ]Length of time from EMS arrival on scene to patient arrives at hospital.
- Use and type of reperfusion [ Time Frame: 24 hours ]Proportion of patients with STEMI who receive reperfusion treatment (pPCI or fibrinolytic).
- Time to treatment [ Time Frame: 24 hours ]Time in minutes from initial EMS call to patients first recorded reperfusion treatment.(STEMI only)
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
|Contact: Lucia Gavalova, BScemail@example.com|
|South Western Ambulance Service NHS Foundation Trust||Not yet recruiting|
|Exeter, Devon, United Kingdom, EX2 7HY|
|Contact: Sarah Black, PhD 00441392261640 firstname.lastname@example.org|
|Contact: Maria Robinson 00441392 261655 email@example.com|
|Welsh Ambulance Services NHS Trust||Not yet recruiting|
|Cardiff, Wales, United Kingdom, CF11 8PL|
|Contact: Nigel Rees, MSc 00442920932903 firstname.lastname@example.org|
|West Midlands Ambulance Service||Not yet recruiting|
|Brierley Hill, West Midlands, United Kingdom, DY5 1LX|
|Contact: Andy Rosser, MCPara 00447825451538 email@example.com|
|Principal Investigator:||Tom Quinn, FESC FAHA FACC||Kingston University & St George's, University of London|